Chemistry, Manufacturing and Controls (CMC)

Robust Strategy and Expert Support

In order to ensure your programs progress on schedule, you need specialised regulatory guidance and support during the drug substance and drug product development processes. Our dedicated global chemistry, manufacturing and controls (CMC) group provides:

  • Global regulatory and product development consultation
  • CMC/toxicology programs that are fully integrated with your product’s clinical and regulatory plans
  • Close collaboration with our GMP laboratory, toxicologists and other business units to provide complete support
  • A wide range of capabilities including pharmaceutical development across the spectrum of new chemical entities (NCEs), generics, biologic products, biosimilars, OTC and consumer health products, medical devices, advanced therapy medicinal products and genetically-modified organisms.

This group provides scientific and regulatory expertise in all areas of CMC development:

labs and early development
Product Development and Regulatory Strategies
  • Fast to clinic – first in man strategies to minimise drug use via compounding in clinic
  • Regulatory documentation and due diligence reviews prior to compound purchase
  • Global, strategic CMC regulatory advice from lab bench to pharmacy shelves
  • Formulation, analytical and manufacturing process development advice on clients’ formulations and drug delivery approaches
Customised Solutions for Small Virtual Companies
  • Full CMC development of drug substance and drug product
  • Man-in-plant services
  • Failure investigations and clinical batch salvage strategies
  • Full regulatory affairs support and technical project management
CMC Regulatory Services
  • Preparation and scientific review of IND/CTA/IMPD/NDA/MAA and ANDA submissions
  • Authoring of annual reports, drug master files, dossier amendments and supplements
  • Preparation, publication and submission of electronic common technical document (eCTD) applications
  • Direct interactions and negotiations with the U.S. Food and Drug Administration, European Medicines Agency and national agencies as client’s agent to facilitate “best case” outcomes
  • Quality by design expertise
Active Pharmaceutical Ingredient (API) and Clinical Trial Material Sourcing and Program Management Capabilities
  • Contract manufacturing organisation (CMO) selection support and project management
  • Scientific/project-specific site visits and cGMP audits to evaluate vendor staff and facility capability to execute the program
  • Scientific interpretation of manufacturing and analytical results
  • Alternative approaches to keep development programs on schedule
  • Advice on setting appropriate specifications and assigning product shelf-life