Quality Regulatory Chemistry, Manufacturing, and Controls (CMC) Dossiers, quality Regulatory Strategy Consulting and Scientific Planning for the post-approval variations. Refer to our service section for further information.

We prepare global regulatory CMC documents based on technical information from R&D/Operations/Quality for submission to FDA, and international regulatory authorities. Maintains awareness of and expertise in cGMPs and CMC related regulations and guidelines.

We assess and communicate global regulatory CMC requirements to ensure all development activities are in compliance with applicable regulations and guidelines. Ensures data and/or summary reports are provided on time to meet internal filing dates, regulatory commitments, or required statutory updates.

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