Chemistry, Manufacturing and Controls (CMC)

Regulatory expertise in all areas of CMC development

Our chemistry, manufacturing and controls (CMC) group provides regulatory guidance in setting specifications, method development and validation and also conducts stability studies. In addition, we identify contract manufacturers, arrange contract laboratory services and conduct good manufacturing practice (GMP) audits.

Product development and regulatory strategies

• Fast-to-clinic and first-in-man strategies to minimize drug use via compounding in clinic
• Regulatory documentation and due diligence reviews prior to compound purchase
• CMC regulatory strategies and advice from lab bench to pharmacy shelves
• Formulation, analytical and manufacturing process development advice on formulations and drug delivery approaches

CMC regulatory services

• Preparation and review of regulatory submissions, including:
  • Investigational new drug (IND)
  • Clinical trial authorization (CTA)
  • Investigational medicinal product dossier (IMPD)
  • New drug application (NDA)
  • Marketing authorization application (MAA)
  • Abbreviated new drug application (ANDA)
• Authoring of annual reports, drug master files, dossier amendments and supplements
• Preparation, publication and submission of electronic common technical documents (eCTD) applications
• Direct interactions and negotiations with U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA) and national agencies

Active pharmaceutical ingredients (API) and clinical trial material sourcing and management

• Scientific/project-specific site visits and GMP audits to evaluate vendor staff and facility capabilities to execute the program
• Interpretation of scientific results
• Alternative approaches to keep clinical development programs on schedule
• Advice on setting appropriate specifications, assigning product shelf-life and conducting failure investigations

Customized solutions for small virtual companies

• Full regulatory affairs support
• Access to preclinical toxicologists and pharmacokineticists
• Access to clinical therapeutic area experts
• Full CMC development of drug substance and drug product