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
- API/DS Process Development
- DP Formulation Development
- DP Process Development
- Analytical Method Development
- Stability
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
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
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
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
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…
