Analytical CMC and QC Consultancy Services post thumbnail

Our Analytical CMC (Chemistry, Manufacturing, and Controls) and Consultancy Services provide expert scientific and regulatory support throughout the product lifecycle — from early development through commercial release. We partner with clients to ensure analytical strategies are scientifically sound, regulatory-compliant, and aligned with global expectations, including ICH, FDA, EMA, and other health authorities.

Whether developing new products, addressing regulatory queries, or remediating analytical challenges, our team combines deep technical expertise with hands-on regulatory experience to deliver compliant, defensible, and phase-appropriate analytical solutions.

Comprehensive Analytical CMC Support Includes:

  • Analytical Strategy Development

    • Establishment of phase-appropriate CMC analytical plans for drug substance and product

    • Alignment of analytical methods with formulation, process, and stability requirements

    • Risk-based method selection and lifecycle management

  • Regulatory & Submission Support

    • Authoring and reviewing analytical sections for IND, NDA, ANDA, MAA, and CTD Module 3 submissions

    • Response preparation for regulatory agency questions and deficiency letters

    • Support for post-approval changes, comparability protocols, and change control documentation

  • Analytical Method Consulting

    • Review, optimization, and remediation of existing analytical methods

    • Development of stability-indicating and regulatory-compliant methods

    • Support for method transfer, validation, and troubleshooting across internal and external sites

  • Data Integrity & GMP Compliance

    • Evaluation of analytical systems for data integrity and audit readiness

    • Implementation of documentation, traceability, and procedural controls per regulatory expectations

    • Guidance on analytical quality systems and best practices

  • Technical Consultancy

    • Strategic support for complex analytical or manufacturing issues

    • Gap analysis and remediation planning for regulatory submissions or audits

    • Review of third-party or legacy analytical data packages for compliance and consistency