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Who are we ?

Regulations are the backbone of any industry. In healthcare this segment is involved with human lives and better jurisprudence results in quality healthcare products.
Regulations are taking shape day by day and stringent markets are strengthening their regulatory systems while nascent markets are upgrading their regulatory systems and preventing the loopholes resulting in Good Regulatory Practices.
Pharma players are facing a number of regulatory issues in order to cope these situations and cancellation of the products, market withdrawal and penalties are some of the worst scenario faced Survival of the fittest is the only theory in present competitive scenario.
We at Regpace as a team of professionals engaged in solving the Regulatory puzzle and can assist you with a number of competitive ways to fix the hectic situations.

DOSSIER Services

Registration dossier preparation, compilation and Review (Regional specific formats e.g. ACTD, CTD, LATAM, CIS etc.). Filing to domestic (CDSCO) and International regulatory bodies.
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CDSCO Service

NDA, IND Approvals from CDSCO.
Medical Writing Service for Non Clinical and Clinical summary reports for clinical trial and Bioequivalence Studies. .
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MEA & EMBASSY

Ministry of External Affairs and Embassy Document Attestation..
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IMPORT & EXPORT

Import Registration Services - (Form-10) Finished formulations, Bulk Drugs, Medical Device, Diagnostics, Test License (Form-11)
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