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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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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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