Prolajm AB – Life Science Adviser and CMC Expert

Anna Holmberg
Senior Project Manager
and CMC Expert

I have more than 20 years’ experience of leading pharmaceutical and medical device development projects in the life science sector, including:

  • Project management of Pharmaceutical and Medical Device development projects
  • Setting up development plans
  • Setting up Target Product Profiles
  • Development of medical device products including product design, verification and validation, risk analysis, biological evaluation, clinical investigations, clinical evaluation
  • CE-marking of medical device products 
  • Preparation and assessment of Technical Documentation for medical devices
  • Setting up and maintaining quality management systems (GLP, ISO 13485:2016)
  • Planning and management of the CMC development process including formulation development, analytical development, stability studies, and manufacturing
  • Outsourcing of laboratory work, product development, manufacturing, pre-clinical and clinical studies
  • Tech transfer to CMOs and CROs
  • Regulatory CMC, documentation for clinical trials (IMPD/IND) and handling of CMC questions
  • Development of formulations, from small scale in the preclinical phases, scale-up during the clinical phase and up to tech transfer for marketed products
  • NCEs, generics, peptides, and small molecules
  • Semisolid formulations (gels, creams, ointments, foams), liquids, capsules, and tablets