Regulatory CMC

Technical advice and support

We provide CMC expertise and support related to manufacturing all the way from the early development phase to post-approval.

Technical advice from development to manufacturing

Working with us you will maintain a holistic view of all aspects of chemistry, manufacturing and control, while keeping the patient and treatment in focus. 

Throughout the product lifecycle, we offer expertise for most types of formulations and indications and for chemical, herbal and biological products.

We provide expertise in all areas of CMC such as:

Active pharmaceutical ingredient (API)

Manufacturing process

Drug product formulation

Excipient selection

Analytical methods and method validation

Container closure and packaging


Why use our support with technical advice and support?

We help you mitigate risks and identify opportunities for CMC compliance from early development to post-market. Our specialists have extensive expertise in drug product formulation, manufacturing, and process development, as well as in analytical method development and validation related to the whole spectrum of drug products, for example:

  • Small molecule drugs
  • Peptides
  • Monoclonal antibodies (mAbs)
  • Recombinant proteins/enzymes
  • Protein complexes
  • Cell therapies
  • Oligonucleotides
  • Biosimilars
  • ATMP
  • Herbals

More Regulatory CMC services:

CMC project management
CMC documentation
Formulation development and manufacturing advice
CMC strategies

Staffan Thunell

Founding partner

BSc Economics and BA

Staffan has a long background in entrepreneurship within the life science industry. He has 20+ years experience from posit­ions as Founder, Chair­man, CEO and CFO within medical affairs consulting and small pharma. Previously Staffan worked in executive positions in big pharma and specialty pharma companies.