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
