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Regulatory & Quality

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  • CRO/CMO oversight

  • Vendor audits (US, EU, Asia)

  • Quality agreements & investigations

  • SOP development & training

  • PAI readiness

Quality Assurance

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Quality Management Systems

Our pharmaceutical quality management systems safeguard your molecule from discovery through GMP manufacturing and regulatory submission. Every process is built on GMP standards and aligned with FDA, EMA, and ICH guidelines to ensure full traceability, data integrity, and reproducibility.

  • IND / eIND / IMPD authorship

  • NDA / ANDA / MAA submissions

  • Control strategy development

  • DMF preparation

  • Regulatory agency meeting support

CMC Regulatory

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