Leading consultancy with expertise in GXP and Regulatory services for the Pharma life-sciences worldwide.

Worldwide Regulatory Strategy

Compile all the required information for the amendment of the CTD dossier and stay ready for regulatory inspections targeting pharmacovigilance.

With our highly flexible and close multicultural teams of consultants expert in the laws and regulations operating in various countries, we help our clients comply and sell their products across the globe.

- Pre & Post Submissions

- DMF/ASMF/CEP Dossiers (CTD/e-CTD Compilations)

- Preparation of Product Registration Dossiers (Quality part)

- Country-Specific Module 1

- Technical Packages

- Life cycle management

- US Agent Appointment

- Regulatory Query response

- Variation/Change Application Dossier

- Reformatting of Documents to eCTD Compliant Submissions

- Dossier Gap Analysis & Review for Drug Products and Drug Substances

- Procedure Management

- Medical Writing

- User testing

REGULATORY AFFAIRS

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