Regulatory Affairs

We understand that regulatory affair is very critical part of clinical research, so we make your life easy by undertaking all your regulatory affairs needs.

Our expertise and experience in understanding Indian regulatory requirements which facilitates swift approvals in India. We can help you to get faster regulatory clearance for your protocols and dossiers.

Our services:

Regulatory Strategy - Strategic design for the global regulatory submissions including the key markets of the UK, EU, USA, and Canada, but not limited to.
Regulatory Submissions - Gap Analysis/ Due-diligence and dossier review.
eCTD review, submission and publication.
Customized support on specific modules as per need can also be provided.
Query Management - Handling query responses from the regulatory authorities.
Life Cycle Management Support - license renewals, annual reports, variation submissions, change of ownership applications, etc.
Labelling Management – PIL, SmPC, US labels preparation, and management of updates.
Bridging studies and user testing/Readability testing in the EU.
General regulatory requirements for the above-mentioned market.
Correct RLD identification/procurement.
Establishing UK subsidiary and arrangement on batch release site/ QC testing lab/QP/MIA
API supplier identification and its evaluation
Regulatory services for the ROW/Emerging market including India Market.
Bio-waiver strategy

Regulatory Affairs

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