Regulatory Affairs

The right knowledge and inbuilt scientific culture is present within our team. Our core and existential feature is the dossier development derived from experience and deploying relevant newer technologies in tandem with market demands. Dossier Development is strongly facilitated by Regulatory Affairs and the urge of Quality Assurance at each milestone covered. A consolidated approach of formulation and analytical development has following features:

Dossier compilation as per

• Common Technical Dossier (CTD) Guidelines.
• Asean Common Technical Dossier (ACTD) Guidelines.
• Country Specific.
• Dossier reformatting to CTD / eCTD by taking up gap analysis of existing dossiers in line with current requirements.

LIST OF PRODUCT DOSSIER AVAILABLE

Writing / Review

• Registration Application & Covering Letter
• Letter of Authorization
• Summary of product (SmPC) and Pack Information Leaflet (PIL) or Pack insert
• Label and carton contents
• Expert Summaries
• Site Master File (SMF)

Supportive Services

• Handling all MoH Queries (till product registration) and Review Dossier as per Updated MOH guideline
• DMF (in CTD format)
• Advice on BE studies
• Drafting Process validation, Stability, PDR & AMV
• Protocols for DQ, IQ, PQ and OQ for equipment’s
• Other GMP documents
• Review of documents and approvals from regulatory agencies to identify gaps and non-compliances

Draft data for

• BMR, MFR
• Process Validation,
• Analytical Validation
• Stability Study reports
• Dissolution profile
• Certificate of analysis and related reports

We can arrange audit as per the requirements of GMP in house or other standards as required by you.

Auditing the following segments

• API / Excipient / Packaging materials Vendor
• Analytical and stability centers
• Formulation and manufacturing sites

All services are customized and available on a modular basis meeting the specific requirements of our clients.