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What is Regulatory Intelligence (RI)?

regulatory intelligence

If we will search for REGULATORY INTELLIGENCE anywhere we will be getting many results and definitions. The act of gathering and analysing publicly available regulatory information. This includes communicating the Implications of that information, and monitoring the current regulatory environment for opportunities to shape future regulations, guidance, policy and legislation.

Regulatory Information collectively comprises of three main segments which are followed while performing Regulatory Information activities:

  • Gather Data: RI professionals perform research about regulatory norms as per a particular product in a particular geography. As far as collecting relevant regulatory information is concerned, there are a lot of sources that RI professionals leverage to consolidate their research material.
  • Analyse Information: This gathered data needs to be filtered out to obtain relevant information as per the purpose. The data filtered is then rearranged having relevant information required according to latest trends and patterns in the regulatory industry. Latest changes in regulatory and guidelines need to be implemented.
  • Regulatory Strategy: The key purpose to perform the above stated undertakings is to come up with the most appropriate and practical regulatory strategy for a company. Different products have different regulatory guidelines in different countries. This is why experts propose a plan of action that outlines an approach as to how to go about regulatory actions for the target distribution markets. However this plan of action is never a task done. It continuously goes forward as the mandates in the regulatory space change.


This function of REGULATORY INTELLIGENCE(RI) typically conducts the following activities:

• Regulatory strategy, development plan or therapeutic area analysis for a product.
• Guidance interpretation and application.
• Due diligence
• Citizen’s Petitions
• Participation or observation of Advisory Committee or other public meetings.
• Identifying regulatory trends and anticipating effect on company and products.
• Monitoring health authority organisational changes.
• White papers or position statements.

Why is Regulatory Intelligence Important?

Provides the regulatory professional with information to:

– Identify opportunities.
• Broader indications, precise pre‐clinical/clinical development programs.
• Expedite development/increase efficiency.
– Identify possible pitfalls.
• Compliance issues, change in requirements for specific indication.
– Predict review times for product and/or change to product.
– Answer specific development questions posed by team.


Benefits of Regulatory Intelligence (RI)
• Increased compliance.
• Increase likelihood of marketing application approval.
• Shorten time from filing to approval.
• Increased efficiency.
• Optimise study design for regulatory endpoints.
• Optimise messaging about product benefit.
• Maximise target market potential.
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Regulatory Strategy


First of all a therapeutic product’s regulatory strategy is a key component of product development. It is important that the regulatory strategy be developed very early in the drug-development process. As soon as the target product profile (TPP) has been determined, the regulatory strategy can be worked out as a pathway to support the TPP. The regulatory strategy is a reverse-engineered document such that once one has developed a TPP (i.e., the objective is established), one can then work backward to determine what information is needed to achieve the goal.

Within a company, there are usually many players from a variety of departments who work on developing the regulatory strategy. furthermore this strategy involves all aspects of a drug, individuals with expertise in chemical synthesis, toxicology, biology, clinical and regulatory affairs, marketing, government affairs, and reimbursement should all provide input into the regulatory strategy to ensure it is as comprehensive as possible.

The clinical trial program should support the regulatory strategy. In other words, if the outcome of a clinical trial is not providing information that is supportive or pivotal to a future marketing application, its value should be questioned — at least in the early stages of drug development or in situations where cost plays a major role.
The main activities involved in creating and achieving a regulatory strategy include:

• conducting intelligence-gathering activities
• obtaining and managing documentation
• obtaining necessary approvals to conduct pre-clinical and clinical studies
• preparing for and attending regulatory authority meetings
• planning, preparing and maintaining regulatory submissions and correspondence
• responding to Agency queries and deficiency letters

Importance of the label and label claims
As part of the target product profile, a draft label will have been prepared. This will list the main proposed claims of the manufacturer. The regulatory strategy can then be developed to support these claims. Thus the TPP dictates key aspects of the clinical trial program.

Key aspects of a good regulatory strategy

A good regulatory strategy involves understanding the key guidelines and emerging policies, as well as the relevant stakeholders that stand between drug development and drug approval.

A good regulatory strategy identifies the pathway and the potential hurdles, and creates a plan that will proactively address any issues that may arise. A good regulatory strategy includes potential regulatory solutions for possible roadblocks.
Novel approaches or drugs with new mechanisms of action can present opportunities. With ongoing developments in science and medicine, the landscape continues to evolve and it is important for regulatory affairs professionals to engage an educational approach with regulators. Those who best understand a new drug are usually those who have developed it.

Thus it can be critical to educate regulatory agencies on how a drug or its mechanism may be unique, and that the existing regulatory guidelines and policies may not necessarily directly apply. Novel endpoints may be needed if the indication is new. This can pose challenges for drug development, but also it presents an opportunity to potentially identify new benefits and new strategies for obtaining marketing authorization.

Based upon the needs of regulators, a good regulatory affairs professional needs to be able to carefully evaluate development options and potential issues and challenges. The regulatory affairs professional is the communications intermediary between regulators and the rest of the drug development and marketing team. These individuals should be key members of the drug development team in order to best address any potential issues with regulators.
Regulatory strategy document
The regulatory strategy document has three main purposes. It needs to be:

• The tracking tool to summarize key agreements reached with health authorities
• The planning tool that documents timelines and lists topics to address in future meetings with health authorities
• The risk register to record key issues that could impact timelines, costs or commercial value for the project

Key components of a regulatory practices could include:

• A summary of relevant guidelines and precedents
• a strategy to optimize product label claims
• lifecycle management
• a global submission strategy
• target submission and approval dates
• special populations and special safety evaluations
• implications of licensing agreements
• regulatory risks
• details on exclusivity
• accelerated development and approval options
• trademark information
• a plan for future interactions with regulatory authorities
• key product-label attributes
• external influencing
• table of advice from regulatory authorities and outstanding commitments

Hence, there is no set way to develop a regulatory strategy. As a result, the Method chosen needs to take into account the company’s goals, over both the short and long term. Most noteworthy there can be trade-offs between speed and cost of development.

Therefore the regulatory method must strike a balance between what the company can afford, therefore what is needed to take the product to market with the identified TPP, and how fast the company can achieve drug development. The regulatory document should be almost a living document that evolves as drug development progresses and more is learned about the product.


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ACTD (ASEAN Common Technical Dossier) is a dossier for marketing authorization of Pharmaceutical / Biologicals / biotechnical products in ASEAN region. ACTD is essentially divided into 4 parts. Each part provides information under specific head.

Part I of ACTD provides admin and brief product information

Part II of ACTD provides Quality related information on the drug substance and drug product.Out of all the parts, the part II is most important. In this one section is completely devoted to QOS and another section is devoted to detailed data on drug substance and drug product. This part not only evaluates technical suitability of the product but also determines the suitability of active drug and Excipients. It consists of 4 distinct parts named e.g. as Part1, Part 2, Part 3 and Part 4.

Part III of ACTD provides nonclinical profile of the product and Part IV of ACTD provides clinical profile of the product For generic products the most important part is Part II. The part III is virtually not required. The part IV is required to the extent applicable to BE studies.

Table 1: Preparation & Compilation of Drug Substance part in ACTD (2-3,4)


The drug substance part is allotted code S and the subsections are listed as S1, S2 and so on. Each subsection is further divided as required


Provide the analytical procedure used for testing the drug substance should be provided in sufficient detail to enable reproducible testing by another laboratory.As far as possible the substance shall be tested as per Compendial methods. However, if the method used is out of compendia the sufficient information on the same shall be provided from the supplier.

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S 1.1 Provide International non–proprietary name (INN),Compendial name ,CAS No ,Chemical name(s)
S 1.2 Provide Structural formula of drug substance
S 1.3 Provide Physico-chemical description, solubility, refractive index , melting point, polymorphism, particle size, chirality of the drug substance
S 2.1 Provide manufacturer’s Name and full addresses including the city and country of the manufacturer of active ingredients.
Also provide Name and address of Contract manufacturers/contract analytical laboratories, if any
S 2.2 Describe the manufacturing process and process in sufficient details
S 2.3 Describe specification and test methods for raw materials, starting materials, solvents, reagents, catalysts as used in manufacturing
S 2.4 Narrate the critical steps along with their standard values and experimental findings.Narrate the critical steps along with their standard values and experimental findings.
S 2.5 Provide Process validation Plan, experimental data and final conclusion. The analytical methods used for validations may be cross referenced / provided suitably
S 2.6 Provide process development details
S 3.1 Describe Confirmation of structure based on synthetic route and spectral studies. Also include Information on isomerism and polymorphism if applicable.
S 3.2 Provide information on general impurities and related products
S 4.1 Provide detailed specification, tests and acceptance criteria for the drug substance. Compendia specifications are adequate. Indicate clearly whether the drug substance is purchased based on specification with a certificate of analysis, or tested by applicant. Indicate if any additional specification are applied
S 4.2 Provide the analytical procedure used for testing the drug substance should be provided in sufficient detail to enable reproducible testing by another laboratory.
As far as possible the substance shall be tested as per Compendial methods. However, if the method used is out of compendia the sufficient information on the same shall be provided from the supplier.
S 4.3 Provide experimental data for the validation of analytical procedure used for testing the drug substance. Cover validation parameters such as specificity, precision, repeatability, reproducibility, accuracy, linearity, range, limit of quantitation, limit of detection, robustness and system suitability.
S 4.4 Provide COA of three batches
S 4.5 Provide justification of specifications if the same are different to those detailed in Pharmacopoeia.
S 5 Provide the source and control No of Primary and secondary Reference standard used for analysis
S 6 Describe the identity of materials of construction of, dimensions, drawings, functional characteristics, test methods for primary packaging materials.
Provide only a brief description for non-functional secondary packaging components. Discuss where necessary sorption ,leachability and safety
Discuss the suitability functional secondary packaging components so as to cover their choice, physical characteristics, compatibility with primary packaging materials
S 7 Provide summary of stability studies conducted, protocols used and the results and conclusions.
Describe the forced degradation studies conducted under stress conditions such as high temperature, humidity and hydrogen ion concentrations. ,
Provide conclusions with respect to storage conditions and retest date or shelf-life, as appropriate.
Detail Post-approval Stability Protocol and Stability Commitment
Provide Results of the stability studies in tabular/graphical.
Provide Information on the analytical procedures used and their technical validity Provide this information from Manufacturer or from your own studies carried on the material.



The drug product part is allotted code P and the subsections are listed as P1, P2 and so on. Each subsection is further divided as required.


Provide information and data on the development of the dosage form under following heads:The composition developmentProcess developmentAnalytical method developmentThe container closure system developmentAssignment of final specification, microbiological attributes and usagesAssignment of stability and retest period.

The compatibility of the drug product or reconstitution diluents(s) or dosage devices, e.g. precipitation of drug substance in solution, sorption on injection vessels and stability should be addressed to provide appropriate and supportive information for the labeling Literature data are acceptableProvide the batch formula with name and quantities of all ingredients (active and otherwise) including substance(s) which are removed in the course of manufacture should be included:State the actual quantities (g, Kg, Liters) etc. of all ingredient State the reason for including the overage State the State total number of dosage unit per batch.Provide description of all stages involved in the manufacturing of the productProvide analytical procedure used for the testing of critical Excipients i.e. substances which affect stability and bioavailability of finished product (e.g. preservative, buffer components, dissolution enhancer, and stabilizer) should be provided.

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P 1 Provide description of the drug product and its composition.
Check that the composition includes list of all components of the dosage form, and their dosage on a per-unit basis (including overages, if any). Further indicate function of each component and its quality standards
Specify the composition of any diluents required for reconstitution before use.
Also indicate the Type of container and closure used for the dosage form
P 2.1 Provide information and data on the development of the dosage form under following heads:

  • The composition development
  • Process development
  • Analytical method development
  • The container closure system development
  • Assignment of final specification, microbiological attributes and usages
  • Assignment of stability and retest period.
P 2.2.1 Provide specifications for Active ingredients.
Discuss special characteristics such Water content, solubility, particle size distribution, polymorphism and chirality if applicable
P 2.2.2 Provide the specifications for Excipients.
Discuss special characteristics such Water content, solubility, particle size distribution if applicable
P 2.3.1 Discuss the development of the final product with special reference to Results from comparative in vitro studies (e.g. dissolution) or comparative in vivo studies (e.g., bioequivalence)
P 2.3.2 Discuss if overages are included in the dosage form.
P 2.3.3 Discuss the physiochemical and biological properties of dosage form
P 2.4 Discuss the development of final manufacturing process.
Provide details on the pivotal batches and validation of three initial batches.
P 2.5 Discuss the selection of the container closure system used for packaging, storage and shipping. The discussion shall cover choice of materials, protection from moisture and light, compatibility, accuracy of delivery
P 2.6 If appropriate discuss microbiological attributes of the dosage form.
If microbial studies are not performed discuss the rationale for the same. Discuss the selection and effectiveness of preservatives systems used.
Address the integrity of the container closure system to prevent microbial contamination in case of sterile products
P 2.7 The compatibility of the drug product or reconstitution diluents(s) or dosage devices, e.g. precipitation of drug substance in solution, sorption on injection vessels and stability should be addressed to provide appropriate and supportive information for the labeling.Literature data are acceptable
P 3.1 Provide the batch formula with name and quantities of all ingredients (active and otherwise) including substance(s) which are removed in the course of manufacture should be included:
State the actual quantities (g, Kg, Liters) etc. of all ingredient.
State the reason for including the overage State the State total number of dosage unit per batch.
Provide description of all stages involved in the manufacturing of the product
P 3.2 Provide flow diagram giving the steps of the process and showing where materials enter the process.
Identify and narrate the critical steps and points at which process controls, intermediate tests or final product controls are conducted.
Describe the manufacturing process in sufficient details to cover the essential point of each stage of manufacture.
For sterile product describe preparation and sterilization of components in detail.
P 3.3 Provide Tests, acceptance criteria and test results for critical steps.
Provide information on the quality and control of intermediates isolated during the process
P 3.4 Provide the protocol and results of validation studies
P 4.1 The specification for the Excipients should be provided.
P 4.2 Provide analytical procedure used for the testing of critical Excipients i.e. substances which affect stability and bioavailability of finished product (e.g. preservative, buffer components, dissolution enhancer, and stabilizer) should be provided.
P 4.3. Provide list of Excipients from human or animal origin separately, if any. (Provide information of sources ,specifications, description and safety data of Gelatin, enzyme, or any such materials )
P 4.4 Provide full details of manufacture, characterization and controls, with cross references to supporting safety data (nonclinical or clinical) for Excipients used for the first time in a drug product or by a new route of administration
P 5 Provide summary of the analytical procedure. Provide validation of methods for impurity profiling and assay
P 5.1 Provide the specifications for the finished product
P 5.2 Provide the analytical procedures used for the testing the finished product should be provided.
P 5.3 Provide protocol and experimental data for the verification of analytical procedures use for the testing the finished product. Provide AMV for non-Compendial methods
P 5.4 Provide Batch analyses results of 3 commercial batches.
P.5.5 Provide information on general impurities and related products
P.5.5 Provide results of characterization and assay of Compendial and non Compendial impurities.
P 5.6 Justification for Compendial products is not necessary.
However, if there is some addition or deletion in Compendial specifications, the same shall be justified.
P 6 Detail the reference standard/working standard used for product analysis. Provide relevant COA
P 7 Describe the container closure systems. Please note that test for identity for polymeric materials is quite essential. The specifications should include description critical dimensions and drawings as appropriate.
For non-functional secondary packaging components provide only a brief description. For functional secondary packaging components, provide additional technical information
P 8 Provide summary and conclusions of stability studies
Provide The post-approval stability protocol and stability commitment, Provide stability data in tabular form
P 9 Provide remarks on Product interchangeability

Additional Guidelines

The designing of ACTD Quality Part is not as easy as it looks. The ASEAN region requires proper information strictly as per the index based on actual experimentation. Data fraud is strongly discouraged.The incomplete, unwanted, falsified information is not entertained for registration. The last but not least the information need to be presented in easily readable format with proper margins, font size and font type.


For the marketing authorization of the drug products ACTD the technical documents subdivided 4 parts is essential. The part 2 is a very critical part of the submission. The information on both the drug substance part and the drug product part shall be included in this part as detailed above.

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GMP(Good Manufacturing Practice)

GMP refers to the Good Manufacturing Practice Regulations promulgated by the US Food and Drug Administration under the authority of the Federal Food, Drug, and Cosmetic Act (See Chapter IV for food, and Chapter V, Subchapters A, B, C, D, and E for drugs and devices.) These regulations, which have the force of law, require that manufacturers, processors, and packagers of drugs, medical devices, some food, and blood take proactive steps to ensure that their products are safe, pure, and effective.

GMP regulations require a quality approach to manufacturing, enabling companies to minimize or eliminate instances of contamination, mixups, and errors. This in turn, protects the consumer from purchasing a product which is not effective or even dangerous. Failure of firms to comply with GMP regulations can result in very serious consequences including recall, seizure, fines, and jail time.

GMP regulations address issues including record keeping, personnel qualifications, sanitation, cleanliness, equipment verification, process validation, and complaint handling. Most GMP requirements are very general and open-ended, allowing each manufacturer to decide individually how to best implement the necessary controls. This provides much flexibility, but also requires that the manufacturer interpret the requirements in a manner which makes sense for each individual business.


All guideline follows a few basic principles:

  • Manufacturing facilities must maintain a clean and hygienic manufacturing area.
  • Manufacturing facilities must maintain controlled environmental conditions in order to prevent cross-contamination from adulterants and allergens that may render the product unsafe for human consumption or use.
  • Manufacturing processes must be clearly defined and controlled. All critical processes are validated to ensure consistency and compliance with specifications.
  • Manufacturing processes must be controlled, and any changes to the process must be evaluated. Changes that affect the quality of the drug are validated as necessary.
  • Instructions and procedures must be written in clear and unambiguous language using good documentation practices.
  • Operators must be trained to carry out and document procedures.
  • Records must be made, manually or electronically, during manufacture that demonstrate that all the steps required by the defined procedures and instructions were in fact taken and that the quantity and quality of the food or drug was as expected. Deviations must be investigated and documented.
  • Records of manufacture (including distribution) that enable the complete history of a batch to be traced must be retained in a comprehensible and accessible form.
  • Any distribution of products must minimize any risk to their quality.
  • A system must be in place for recalling any batch from sale or supply.
  • Complaints about marketed products must be examined, the causes of quality defects must be investigated, and appropriate measures must be taken with respect to the defective products and to prevent recurrence.
  • GMP is also sometimes referred to as “cGMP”. The “c” stands for “current,” reminding manufacturers that they must employ technologies and systems which are up-to-date in order to comply with the regulation. Systems and equipment used to prevent contamination, mixups, and errors, which may have been “top-of-the-line” 20 years ago, may be less than adequate by today’s standards.

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Pharma-IP Capabilities


ip capabilities


First of all Ip capabilities are a part of pharma industry. A pharma Document or regulatory document is useful if certain things are done accurately because We deal with pharmaceuticals that means many lives depends upon us and we have to recheck everything as we are related to world’s health. Even a single mistake can take million lives.hence we have to be very careful every time


Following are some of the Pharma IP Capabilities

➢ Review of literature.

➢ Evaluation of patents and planning of non-infringing route (if required).

➢ Strategy planning and execution of formulation development work.

➢ Searching of formulation patents.

➢ Analyzing and interpretation of claims.

➢ Suggesting non-infringing formulation for Formulation & Development


➢ Drafting composition patent and prosecuting for different patent offices.

➢ Preparation of invalidation ground for different patents.

➢ Having patent searching, analyzing skill for ROW markets like Thailand,

Vietnam, Taiwan, North American Countries etc.

➢ Preliminary Patent Assessment Reports.

➢ Level clearance reports/ Freedom to operate reports for various markets.

➢ Drafting of Patent

➢ Prior Art Search / Patentability Search or Novelty Search using various


➢ Global Launch Calendar for constraining patents in issue.

➢ Searching patent equivalents in ROW countries, finding legal status and

giving IP comments.

➢ Giving possible entry dates for major markets & ROW countries.

➢ Patent Infringement Analysis for US, Europe, Australia, Canada & few ROW


➢ ANDA filing strategy for patents in Orange book.

➢ PPT’s for customer meetings based upon requirement & customer interest.

➢ Strategic opinion reports for the Invalidation or Non- infringement of


➢ Preliminary Reports for DCGI filing.

➢ Pre Grant opposition filings in India.

➢ Trade Mark Search.

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therefore you can check the website of government about all other acts and guidelines of the regulatory affairs of india Government site

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