Genedrift is a regulatory partner working towards managing all activities relating to Regulatory Services for Pharmaceuticals. Operating in all segments - starting from Product Development, Quality Management Systems, Dossiers (CTD, ACTD & Regional Formats), Registrations, Strategy & Planning, Regulatory Consultancy, Product Life Cycle Management and Pharmacovigilance, whether review of Cases and Safety Report or preparing of Safety Reports, Genedrift works on delivering quality results for its partners, across the entire business value chain. 

Product Development and Dossier Preparation

Actively operating in this segment, we provide complete solution starting from Development to Approval.

• Preparation / Review of Validation Protocols
  
• Dossier Preparation, Dossier Review - Gap Identification
• Submission with Regulatory Authorities
• Post Submission Support / Handling of Queries

Product Life Cycle Management

MA applications and License Holding is one part of the complete process. Once MA is obtained, each product needs continuous monitoring to ensure that commercial batches are in line and compliant with the regulations. Even a small Change Control, without effective impact assessment can lead to suspension of registration or an import alert for the complete manufacturing site.

We handle the complete product life cycle, starting from receipt of MA, Variation and Compliance Applications, up to filing of Renewal and receipt of Renewals.

At Genedrift, each registration is given enough importance to ensure that nothing stays out of standards and each manufacturing and supply activity is in line with submissions made.

Package Insert (PIL / SmPC) & Artworks / Pack Management

Often companies have come across a situation wherein their artworks are not compliant with one or the other regulatory requirements, either for lack of content in the package insert or out-dated information. In many cases, this leads to increased cost of inventory destruction and regulatory compliance with the authority, and multiple change controls / processes internally leading to poor efficiency. We specialize in reviewing the artworks whether for one country or for a group of countries and can also help in devising strategy on regulatory submissions ensuring one pack is submitted throughout ensuring maximum efficiency.

Our expertise

 - Pre-Submission Meeting and Classification / Clarification from Health Authorities 

 - Due Diligence, Compliance and Gap Analysis

 - Regulatory Resource Staffing

 - Regulatory Affairs Services