Regulatory Services

Our team has expertise in assessing emerging regulatory trends, developing strategies and defining process improvements that facilitate the drug approval and registration process. With our regulatory expertise, we provide strategic advice and support throughout the entire clinical study lifecycle – from planning & submission to post-market surveillance.

Our regulatory services include:

GenBiosis provides regulatory support for its clients by acting as a guiding link between the sponsor and health authorities. We understand how critical is the scientific documentation for successful product rollout in a compliant manner.

Our regulatory services include:

CDSCO Application / Approvals
Regulatory support at developmental stage (protocol writing for BA/BE studies, Phase I Phase IIa/IIb , Phase III and Phase IV, BE NOC and Import license)
Dossier Gap Analysis and Dossier Support Services
Clinical Study Report-writing
Pre-IND application/scientific advice meetings.
Dossier Gap Analysis and Dossier Support Services
Preparation and Translations (SmPC, PIL & Labelling)
Module e-CTD Compilations
Control correspondence

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Regulatory Services

Contact

info@gen-biosis.com

Corporate office and BA/BE Centre, Majestic Plaza, Sr. No. 21/5, Near Manipal Hospital, Kharadi, Pune – 411 014, Maharashtra.