Regulatory services

We leverage our experience in everything – from R&D to process innovation to navigating the complex global regulatory arena – to help clients efficiently develop and manufacture quality products  • Small Molecules
  • Carbapenems
  • Glycans
  • Peptides qq...

Asymchem’s oligonucleotide technology platform provides clients with full services in drug substance, from process development through GMP manufacturing, and drug product, from preformulation development through fill-finish. The process chemistry, analytical, formulation, and regulations teams collaborate ...

Asymchem understands that early phase work focuses on learning as much as possible about a drug compound. Our experience across numerous chemical classes and multiple dosage forms, and our ability to develop analytical methods to assess chemical identity, purity, compatibility, and stability, makes us a na...

Driven by curiosity and the desire to break new ground, leading scientists and technologists are attracted to Asymchem’s culture of innovation. It’s a culture built on operational agility and flexibility, a willingness to invest and share risks, and demonstrated expertise in strategic collaboration and partnership.

Working from this forward-leaning posture, Asymchem successfully supports products at every stage of the lifecycle from preclinical to large-scale manufacturing, with custom development services ranging from investigational new drug (IND) support to Phase III clinical trials and technology transfers for commercial supply.