CMC Services
The Venn Chemistry, Manufacturing & Control (CMC) team of consultants helps clients during Drug Development. The team has experience in both early and late development for New Chemical Entities (NCE) / Small molecules, New Biological Entities (NBE) / Large molecules, antibody-drug conjugates (ADCs) and Generics/Biosimilars.
Working with one of our CMC consultants provides you access to knowledge of an experienced CMC team. If you need a specialist on a project in your organisation or an all-round consultant for your (biotech) start up, contact our team at getintouch@vennlife.com to discuss your requirements.
- Writing Quality Target Product Profile (QTPP)
- Writing Drug Development Plan (DDP)
- Performing Due Diligence and GAP Analysis
- Advising, supporting and managing critical quality issues during CMC Development
- Performing criticality/risk analysis and developing risk mitigation strategies to minimize impact on CMC project timelines
- Selecting a Contract Development and Manufacturing Organization (CDMO)
- Advising, supporting the client in managing the CDMO during process development, analytical development, design of stability studies and other activities at the selected CDMO
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- API/DS Process Development
CMC activities include but are not limited to synthesis of tox batch and clinical GMP batch, extractables/leachables, choosing the desired solid form of API/DS and writing and /or review of documents e.g. reports, batch records, protocols
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- DP Formulation Development
CMC activities include but are not limited to design of DP formulation for clinical trials and marketed products, excipient choices (i.e. pH-adjusting agents, buffers, stabilizers, preservatives), API-excipient compatibility studies (i.e. stress testing), management of formulation changes during development and writing and /or review of documents e.g. reports, batch records, protocols
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- DP Process Development
CMC activities include but are not limited to process design either minimal, QbD or mixed approach, process validation (EU) or PPQ (US), elemental impurities, extractables/leachables and writing and/or review of documents e.g. reports, batch records, protocols
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- Analytical Method Development
CMC activities include but are not limited to selection of methods, methods development, qualification and validation, salt-screening and polymorph studies, stress studies, structure elucidation, characterization, physico-chemical comparability studies, setting of specifications and writing and/or review of protocols and reports
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- Stability
CMC activities include but are not limited to developing a stability strategy/study for DS/DP development batches, statistical analysis and optimizing/minimizing stability design
- Developing regulatory strategy plans
- Providing regulatory affairs CMC consultancy
- Writing regulatory dossiers (IMPD/IND, IB, CTD (module 3/2.3)
- Supporting scientific advice
- Regulatory lifecycle management
- GMP audit / GMP readiness check
- Compliance check / Second Person Review
Integrated Drug Development at Venn
From Discovery to Market – we can help…
