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Regulatory
Affairs
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Regulatory Affairs
Well experienced regulatory affairs team with more than 15 years of experience in regulated market
Regulatory affairs is well versed with regulatory guideline of USFDA/UKMHRA/EMEA/TGA/HEALTH CANADA
Regulatory affairs is adapt in compiling of ANDA’s/ACTD & eCTD dossiers
Regulatory affairs team has a deep knowledge of registering products in EUROPE true National/ CMS /RMS/ MRP procedures
Intellectual Property Management Cell (IPMC)
Akriti IPMC houses is a well experienced & skilled team with technical knowledge in Pharmaceutical Sciences.
Akriti IPMC is a skilled in patentability analysis, filling national & international patent applications
IPMC is an indispensable support for elucidation of R&D product pipeline and product filing strategies