non-GMP

Supporting Risk-based GMP Implementation

For early phase programs under time and quality pressures, Asymchem has implemented a risk-based non-GMP approach that includes a road map that incorporates increased GMP over time. The flexibility to include non-GMP solutions, considers the client’s immediate needs as well as the longer term commercial requirements.

Our cross-functional team from process development, quality and regulatory affairs have substantial experience in successfully introducing chemical steps from non-GMP to GMP scale up and thus driving small molecules APIs or drug products to commercialization with full regulatory compliance.

Expert counsel for GMP requirement determination

• Fast delivery to move the project forward
• Maximum flexibility and better budget control for early phase projects
  • Clear understanding of phase appropriate regulatory requirements
  • 857.9m3 total facility capacity dedicated to Manufacturing & R&D
  • Back-integration of large scale hard-to-find raw material non-GMP production

Contact our expert for a regulatory assessment and discuss the suitability of non GMP for your development stage project including IND-enabling project.