Afra Pharma Consultant - Pune, India

We are a leading pharma consult center based in Pune, India. We cater to all the activities related to Pharma companies.
We specialize in regulatory support and can cater to all your needs.
We are a one stop solution for Pharmaceuticals.

Our Strenghts:
· Regulatory Support (Regulated and Semi regulated markets)
· CTD, NeeS, eCTD, DMF (Saudi FDA & GCC as well)
· Dossier Support ( Ready ACTD and CTD dossiers)
· Clinical Trial Management (CTM).
· Clinical Data Management .
· we support end-to-end CDM activities as per GCDMP and 21 CFR Part 11 compliance.
· Bio-Statistics and Statistical Programming
· We have strong proficiency across the end-to-end medical writing portfolio including Protocols, IB, CRFs,  

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ICFs, CSRs, Medical Manuscripts etc. wherein we have standard ICH E2, E3, E6 and Schedule Y based templates, CRF libraries of standard panels to provide rapid turnaround.
· Clinical and pre-clinical expert reports.Module 3 quality Report
· BA/BE Studies Clinical Trials
· Contract Manufacturing
· Technology transfer (All formulations & API)
· Exports and tenders
· Turn-Key Pharma Projects
· Pharma Training
· Ready to fill pellets
· Joint Ventures