CMC Development Services
CMC Development Services can help you manage projects from the early research phase to commercialisation of the product. This includes strategic as well as operational aspects of CMC development, thorough understanding of the interfaces to the preclinical and clinical areas and the regulatory requirements. We can work project specific or as an addition to your team resources and competences. Our track record includes development of small molecules and biologics, including advanced therapy medical products (ATMP).
Areas of expertise
Our senior CMC Development Services specialists have much experience in the pharma, biotech and generics industries.
KLIFO CMC Development Services assists clients with:
- CMC project management
- Expert support in formulation and analytical development
- Development of quality target product profiles (qTPP) and identification of critical quality attributes (CQA’s)
- Implementation of Quality by Design (QbD) in drug development
- Performing and facilitating root-cause investigations
- Upscaling of manufacturing processes and transfer to CMO, including management of CMOs
- Preparation of reports and documentation to support regulatory filings
- Planning and conducting of CMC due diligence (DD), including report and recommendation
Drug and medical device development plans usually target an international market. While most of our clients develop their products for Europe and the U.S., there is a growing demand for support with regulatory approvals and lifecycle management for other markets.
Our CMC experts have much experience in interacting with authorities in Europe, including Russia/CIS (EMA, national agencies and notified bodies), the U.S. (FDA) and Japan (PDMA).
Director, CMC Development Services
T: +45 44 222 912