Chemistry, Manufacturing and Controls (CMC) Consultancy

Ensuring safe and effective products through well-defined drug substances and test methods

To appropriately manufacture a pharmaceutical or biological product, a well-defined drug substance and product, manufacturing process and test methods must be developed in order to ensure that the product is safe, effective and consistent between batches. Which is a prerequisite to get regulatory approval to study an investigational medicinal product on humans. Collectively, these technical activities are known as CMC, chemistry, manufacturing and control. CMC plays a crucial role in all stages of the product life cycle including early and late phases of development and even after marketing authorization when the product is on the market. CMC covers a wide range of activities including product, process and test method development, product stability testing, phase appropriate validation, packaging development, including combination medical devices and manufacturing and testing under GMP conditions.

Venn’s CMC experts seamlessly integrate with your in-house team

Through a diverse team of highly-qualified and experienced Project Managers, Technical Leaders, CMC Regulatory Specialists and Quality/GMP specialists, we offer expert consulting services that cover all aspects and stages of Chemistry, Manufacturing, and Controls (CMC) pharmaceutical and biological product development supporting small, midsize and large (bio)pharma companies. Venn’s CMC experts can seamlessly integrate with your in-house experts and participate in multi-disciplinary development teams to facilitate your product, process and method development.

Venn Life Sciences can support you in:

CMC management and strategy development

Defining CMC development strategy
CMC Project Management
Technical CMC due diligence and gap analyses
CDMO selection and management
QbD support including Risk Assessments and Design-of-Experience (DoE) study design
GMP Audits and inspection readiness assessment and support

Drug Substance process development

Drug substance formulation
Manufacturing process
Design of stability studies
Writing and reviewing of documentation

Drug Product formulation & process development

API-excipient compatibility studies and early phase: “fit for purpose” formulations
Formulation of parenterals, oral solid dosage forms and lyophilized products
Immediate, delayed and prolonged release formulations
Process design and validation
Design of stability studies
Writing and reviewing documents
Packaging selection, including combination medical devices

Analytical Development

Selection of methods, method development, qualification and validation, and method transfer
Designing and evaluation of product stability studies
Design and evaluation of method qualification, validation and transfer studies
Design of comparability studies
Product specification setting
Writing and reviewing of documentation

ATMP development

Scientific and regulatory input and guidance on design, execution and coordination of CMC strategy
Preparation of gap analysis, Target Product Profile and/or ATMP Drug Development Plan
Support specific production development
Support analytical method development (e.g. potency test)
CDMO management including review of documents (e.g. protocols, reports, SOPs)
Authoring and/or review of Quality module for regulatory submission (e.g. IMPD, IND)