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Chemistry, Manufacturing & Controls (CMC)

Overcome regulatory, scientific and technical challenges ensuring compliance, flexibility on the production capability and on-time delivery.

A vital part of the clinical trial, marketing application, or post-approval strategy is CMC (Chemistry, Manufacturing and Controls). We help you reach your next milestone by providing scientific and regulatory expertise in all areas of CMC development.  In order to ensure your program progresses as scheduled, you need sharp specialized guidance and support during Drug Substance and Drug Product development. At VCLS, we understand how to anticipate and overcome potential difficulties in the development of new chemical entities and biologics, including cell and gene therapy. Our team can also help you with post-approval strategies.

Bridging Technical and Regulatory Expertise

Our CMC experts in the US and EU cover global development taking into account both the FDA and European Health Authorities guidance.  They pragmatically address the various regulatory and technical aspects of CMC, as required by your product complexity and taking into consideration the stage of your development, as well as the evolving quality and regulatory environment. They have navigated at the interface of regulatory, scientific and technical challenges while keeping close interactions with nonclinical and clinical colleagues, as well as regulatory agencies and experts.

We know that innovation is often driven by small to medium-sized companies; therefore, we provide services adapted to your budget and timelines with prompt reactivity and flexibility as a high-quality extension to your team.

CMC Regulatory Activities

  • CMC strategic development (meeting requests, pre-IND, EOP2, pre-NDA, Type C and Type D Guidance meetings)
  • Conduct CMC gap analysis assessment
  • Management of control correspondences
  • Assess change controls and provide submission strategy
  • Prepare CMC section for Annual Reports
  • Prepared CMC Amendments
  • Granulate, convert IMPD into Module 3 eCTD and Module 3 to IMPD
  • Agency meeting preparation (and lead them)
  • Reorder DMF/VMFs, IND/IMPD, BDA [505(b)(1) and 505(b)(2)]/BLA/NDAS
  • BLA/NDA/MAA/IND/IMPD/Drug Management Program (DMPs) preparation and Life Cycle Management Support
  • Responses to Agency Questions
  • Adaptation EU/US
  • Post-approval maintenance and Life Cycle Management (LCM)
  • GMP requirements and marketing compliance
  • Supporting 505(b)(1), (b)(2) ANDAs, DMFs, VMFs
  • Due Diligence

CMC Technical Advisory

  • Post-approval CMC Commitments
  • Manufacturing and Quality
  • Analytical Method Development/Validation
  • Potency Assay strategy
  • Packaging and Labeling
  • Stability strategy across all phases of development.
  • Immunogenicity Risk Management Plan
  • Release and Stability, Specifications
  • Process Development and Validation, QbD
  • Identification of CMO, Technology Transfer and Comparability

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Our Approach

  1. We start from the science and our client’s objectives.
  2. We help our clients take distance from immediate issues, placing them within a global scientific and regulatory context.
  3. We aim to complement both your expertise and resources.

VCLS Expertise