pharma actd dossierspharma Regulatory documentationPharma ACTD DossiersDossiersdossierspharma
Pharma Company with

Dossier Services

Phamra Dossier

Our Services

ACTD Dossier

CTD Dossier

Pharma Company

relationship with clients, based on the highest levels of

integrity, professionalism and trust.

PharmaActDossiers BE Studies Clinical Trials PSUR

Our aims to be global leader in the area of regulatory services, dossier compilation & compliance and also to provide valuable solutions to the clients

Phamra Dossier

Our Services

ACTD Dossier

CTD Dossier



 

 

Dossier

 

Introduction to Dossier and Pharma ACTD Dossiers

first of all, Dossier is a data component having information about a drug. Pharma ACTD Dossiers is the healthcare industry’s No. 1 choice for regulatory affairs services in India. We provide consultancy on regulatory affairs in pharmaceutical and almost any other related industries where regulations are continuously evolving and more scientific expertise can create a difference.

Our Work

We are doing very well since last passed 5 years in the field of pharma regulatory documentation. In addition, Regulatory Affairs Consultation Product Classification, Laboratory Testing, Medical and Lingual Translation, Manufacture Registration, Product Registration and Advertisements Approvals.

Introduction

Pharmaceutical industry is regulated to a variable extent across the world. While Regulatory agencies require Pharmaceutical Dossiers to gain approval to market drugs. The Pharmaceutical Dossiers comprises of various documents representing years of research. This Research includes multi-disciplinary information (including pre-clinical/clinical data) regarding the safety and efficiency of a drug.

Pharmaceutical Dossier Management

Because The regulatory process requiring Dossier Submissions vary from country to country. It involves numerous interactions between the submitting company (sponsor) and the regulatory authority (agency).

Therefore The burden of compiling documentation and presenting it in a compliant format rests on the sponsor’s (company’s) shoulders. This process is very complex involving considerable costs and requiring management of all the components during the approval process.

Our core focus is to offer supportive services to Regulatory Departments of Pharmaceutical Companies in the field of Registering Pharmaceutical Dossiers. We are have been involved with all aspects of regulatory affairs, For example,  Clinical trials, bioequivalence reports, validation data, Expert reports, Data for Overview, PSUR through registration activities, compilation of Pharmaceutical dossier and application for registrations of medicines and E-Filings to post-marketing regulatory obligations for Pharma Industry.

finally Pharmaceutical dossier is highly detailed/exhaustive document on the drugs which requires extensive data’s on its various aspects. Document compilation requires skills of sourcing, interpreting and writing this document. In conclusion, This process of Pharma dossier compilation needs a talented team of pharmacists, data analysts and research assistants. Therefore the entire procedure is highly time consuming and costly. For this Pharma dossier compilation and writing.

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THE PEOPLE WHO WILL SERVE YOU Expert peoples in Our Team

  • Pharma Actddossier Service prepare dossier as per European CTD / ASEAN CTD / non-CTD(country specific guideline)

    Surgeon Skills30%
    Cardiology Skills60%

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    Contact

  • Focus on our strength, which is our existing range and market share. With this strength, PharmaActddossiers Service aims to sustain the current market share and achieve sustainable growth to expand in the current and emerging markets in Asia and beyond

    Surgeon Skills30%
    Cardiology Skills60%

    Contact Us

    Contact

  • Formulation Product Development- Analytical Development and Validation. Process Validation.Stability Studies.Dossier Compilation.Patent Review and Analysis.Bioavailability studies with well-known partner-CRO (USFDA, MHRA, DCGI etc).PSUR.Clinical Trials

    Surgeon Skills30%
    Cardiology Skills60%

    Contact US

    Contact

  • Complete database Quality services On-time delivery Complete dossier solution

    Surgeon Skills30%
    Cardiology Skills60%

    Contact Us

    Contact

  • The regulatory process requiring Dossier Submissions vary from country to country and involves numerous interactions between the submitting company (sponsor) and the regulatory authority (agency).

    Surgeon Skills30%
    Cardiology Skills60%

    Contact US

    Contact

  • Focus on our strength, which is our existing range and market share. With this strength, PharmaActddossiers Service aims to sustain the current market share and achieve sustainable growth to expand in the current and emerging markets in Asia and beyond.

    Surgeon Skills30%
    Cardiology Skills60%

    Contact Us

    Contact

  • Formulation Product Development- Analytical Development and Validation. Process Validation.Stability Studies.Dossier Compilation.Patent Review and Analysis.Bioavailability studies with well-known partner-CRO (USFDA, MHRA, DCGI etc).PSUR.Clinical Trials.

    Surgeon Skills30%
    Cardiology Skills60%

    Contact Us

    Contact

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