CMC Services

Confidence Beyond Compliance

Chemistry, Manufacturing and Control (CMC compliance) is an important component in the lifecycle of a medicinal product, but is one that is continually challenged by many factors, including:

• Merger and Acquisition (M&A) programs – where significant numbers of product licenses are transferred.
• Increasingly complicated networks of internal / external CMOs, and
• Insufficiently robust internal processes in place within an organization to manage complexity and cross-functional interfaces.

These factors often lead to compliance issues, which may have serious consequences from a delay in product approval requiring corrective actions up to product recalls and the loss of marketing authorizations. Our team of CMC and Quality experts will help you make your compliance proactive and in line with health agencies’ requirements, supporting the uninterrupted supply of medicines to patients.

A PharmaLex solution that meets your evolving needs:

• CMC due diligence (e.g. in-licensing activities) / gap analysis
• Product / patient impact assessment
• Development and implementation of risk-based gap remediation plan
• CMC and technical writing
• Root Cause Analysis of gaps in CMC information
• Preparation for regulatory health authority inspection (incl. CAPA-management)
• CMC maintenance support: change control and quality variations
• Design, development and optimization of your GxP-quality system
• Product scope includes human and veterinary medicinal products comprising all types of APIs (chemicals, biologicals, biosimilars, herbals & homeopathic)

If you would like to discuss your requirements with us to see how we might be able to support your product development process, please contact us on contact@pharmalex.com.

25+ years of experience in global regulatory maintenance support and CMC

100+ CMC experts worldwide

500+ quality overall summary expert reports prepared

Proven track record with 6000 successfully completed projects