Our CMC team has vast experience in CMC planning, management, implementation and regulatory strategy, applying knowledge from our involvement in the biowaiver initiatives at the FDA, developing SUPAC-MR, SUPAR-IR and IVIVC guidances.

Working actively with clients on formulations and manufacturing controls/specifications for both new chemical entities and new formulations of approved products, our expertise includes:

• Providing the scientific & regulatory strategy for the CMC plan from proof of concept through to commercialisation
  Applying SUPAC & biowaiver principals throughout all phases of development
• Managing the CMC process, including technology transfer
• Reviewing, compiling or writing all information & reports for the CMC section of regulatory submissions
• Utilising the latest regulatory approaches & techniques for design, development & approval of controlled release oral & parenteral dosage forms
• Determining optimal formulations
• Evaluating innovative drug delivery systems & drug candidates for delivery systems
• Analytical method development & validation