Regulatory Services
Odi Reg group can provide end to end global regulatory affairs services across all phases of product development starting from the Pre-clinical to post approval submissions of different pharmaceutical and biological products. We also provide services for different regulatory strategic Plans, Regulatory strategy (CMC), various tactical solutions providing regulatory agency meeting support, regulatory project and portfolio management for different group of pharmaceutical products.
We are a team of regulatory consultants who provide high quality authoring of Pre INDs, INDs, NDA, ANDA, BLA, Briefing Package, MAA, MRP, DCP, NP, amendments, supplements, Variations, annual Reports, Renewals, Work sharing, pSUSA, PSUR, Core Package for US, EU and other global markets in eCTD format as required by health authorities.
Regulatory Strategy: This includes planning for regulatory submissions(Drug Substance and Drug Product), timelines, and compliance with evolving regulatory standards.
* Pre Publishing Activities, Regulatory Objective Preparation, Import in Veeva, Providing Access in Veeva.
Meet Our Lead Instructors
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Chris Parker
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Number Speaks
10+
Awards
5+
Countries
12+
Partners
7K+
Students
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