Chemistry, Manufacturing, and Controls (CMC)

Expert guidance. Regulatory insight.

PharmaNet regulatory and pharmaceutical experts can guide you on formulations and manufacturing controls/specifications for both new chemical entities and new formulations of approved products. Through their experience and practical knowledge of the drug development process, PharmaNet consultants provide strategic regulatory insights and important recommendations on selecting the optimum formulation, identifying and managing capable vendors, and validating a bioanalytical assay method. PharmaNet consultants can help you:

• Select the best API candidates
• Identify qualified vendors for cGMP manufacturing
• Develop stability studies and programs
• Select compatible excipients
• Determine optimum formulation for the intended route of administration
• Manage clinical-supply manufacturing
• Prepare CMC summaries for regulatory submissions
• Consult on GMP training and feasibility audits
• Write standard operating procedures
• Meet with regulatory authorities on CMC issues