Rahul Solanki

Preparation and submission of Dossiers with review of related documents for UK and Europe market Preparation of Regulatory Strategy Documents by searching UK and EU agencies database for product development Review of Development Documents like PDR, Q&Q, AMVs etc. Review of GMP Documents like BMR, PVR, HTSR, Spec, STPs etc.

Preparation of Dossiers with review of related documents for Europe market Preparation and Submission of CEP to Europe with Deficiency response Preparation and Sharing of China DMFs to Customers with response

Preparation, Review, Submission and Life Cycle Management of USDMF Preparation of ANDA under guidance Preparation and submission of Dossiers with review of related documents for Europe market Preparation and Review of Product Label and Pack-insert

Preparation, Review and Submission of USDMFs/CEPs/MFs to US-FDA, EDQM, Health Canada etc. Maintaining the life cycle of submissions i.e. Annual reports, Amendments, Revisions etc. Handling of Regulatory Agency Queries (i.e. USFDA, EDQM, ANVISA, Health Canada etc.) Customer correspondence for Applicant’s part, Restricted part, Technical packages and Query responses Markets Handled: USA, Europe, Canada, Brazil, other ROW etc.