IPM helps client in regulatory compliance of API & Formulation for regulated and emerging markets. We assist in registration services with various regulatory agencies wrt the following:
- Drug substances/Bulk drugs and intermediates [Regulated & Emerging markets]
- Drug products [Regulated markets & Emerging markets]
- Drug substances/Bulk drugs and intermediates
- Preparation and submission of DMF [USDMF, ASMF] to regulatory agencies
- Gap analysis of ready DMF
- Handling deficiencies
- Preparation and Submission of CEP dossier
- Genotoxicity study report
- Life cycle management [Annual updates, amendments, revision-renewal]
- Drug products [Emerging markets- Asia, Africa, Latin America, Central America and CIS countries]
- Dossier writing
- ICH CTD, ASEAN CTD and country specific formats
- Prepare documents for Company registrations in various countries
- Convert ICH CTD dossiers to ASEAN CTD dossier
- Review, evaluation and Gap Analysis for compiled dossiers
- Respond to deficiencies raised by regulatory authorities
- Renewal of registrations
- Prepare documents to file variations in case of registered products
- File GMP applications to arrange GMP inspections
- Prepare /review Site Master File
- Prepare SMPC/ PIL/ text for artworks
- Quality Overall Summary
- Drug products [ANDA submissions ]
- Gap Analysis of ready dossier
- Module 1: Preparation of Administrative and prescribing information
- Module 2: Summaries and overviews by expert for Quality, Clinical and nonclinical
- Module 3, 4 and 5: Dossier writing
- Compilation of CTD modules in eCTD format
- Structured product labeling (SPL)
- Response to deficiencies
- Drug products/Formulation [Eu submissions ]
- Gap Analysis of ready dossier
- Dossier writing for MAA
- Summary writing for Module 2
- Literature references for Module 4 and Module 5
- Conversion of CTD or NeeS format to eCTD
- Preparation of SmPC, PIL
- Response to deficiencies