Increase efficiency with one expert covering all CMC key disciplines

CMC is a complex multi-disciplinary function, critical for a fast and successful development. The transition from pre-clinical to the First In-Human study is particularly challenging as Quality and Regulatory compliance need to be addressed besides the technical questions. Having one expert with the oversight of the CMC key disciplines is not only reducing the number of vendors and also saving your time. It allows to detect early interactions, recognize the limitations of each discipline and take the best decisions to accelerate your time to approval.

CMC & More supports you by

Guiding through the regulatory CMC requirements (EU, US)
Assuming on or the other function and taking care of the daily business
Advising you in specific questions at strategic and tactical level
Standing at your side as sparring partner in your decision making process

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Drug Substance – Synthesis

Small molecules and penicillin derivates
Characterization solid state (i.e. X-Ray, DSC, Laser Diffraction)
Technical requirements for submission of Active Substance Master File (ASMF)
Review of ASMF

Drug Product – Formulation

Selection of dosage form based on preliminary Target Product Profile
Formulation matrix and feasibility studies with NCE’s (mainly small molecules)
Specific experience i.e. with pulmonary drug delivery formulations, lyophilization, spray drying, liposomes
Planning of Design of Experiments (DoE) and evaluation of data
Root cause analysis

GMP Manufacturing

Particularly solid and liquid sterile manufacturing, liposomes
Review process development reports
Review Master and Executed Batch Records
Develop design space (QbD) with critical process parameters
Technical transfers

Control

Analytical method development, especially chromatography
Characterization of all types of impurities and risk assessments
Review of method transfer/validation protocols and reports
Selection of Critical Quality Attributes, specifications and justifications
Interpretation of stability data, trending

Quality Assurance

Set-up of QMS system (GMP) for PhI organizations
Management of changes, deviations, OOS
Sparring partner of QP, coordination of activities in release process
Qualification of vendors incl.co-auditor activity
Authoring/Review of Technical Quality Agreements

Regulatory

Support in CMC submission strategy, gap analysis
Authoring/Review of Quality section of IND/CTA, NDA/MAA
Preparation of/participation to scientific advice meetings
Authoring/review of responses to regulatory authorities

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