Assignments where we have provided customer support
Confidentiality and integrity are a big part of our relations with customers – below we list examples of work that we have performed. You are welcome to contact us for references for assignment relevant to your needs.
Pharma – Regulatory affairs
- For small and midsized pharma, as well as veterinarian, companies acting as the complete regulatory Affairs function.
- Successfully managed DCPs for companies, including up to 17 countries
- Compilation of dossiers and submission of eCTD sequences for several mid-sized companies
- Updating of old files and strategies for geographic expansion of approval through Repeat Use Procedures (RUP)
Pharma – Quality Assurance
- Set up of GDP/PV system in a start-up, supported the system and trained QA personnel to work in the system. Company grew largely and is now a part of one of the major pharmaceutical companies in the world.
- Joint audits for 10 companies
- QA support as responsible person or qualified person in many companies
- Aciting as local PV office managing complaints medical information, and local PV for Nordics for international company
- Taking on the role of QA/RA manager, and PRRC for small medical device companies
- From MDD to MDR for a company with +30 products in less than 6 months, including urgent rewrite of BER, BEP, CER, CEP and risk assessment. MDR certification at the end of the project.
- Classification of products and proposal of regulatory strategies
- MDSAP audits
- For startup company – development project for a new formulation of a known molecule. Covering all aspects of pharma and medical device QA and RA, including implementing design controls and QP function, to integrate the whole.
- For midsize company development product for drug-device combination product. Implementing device related procedures to ensure compliance with US combination product Quality System requirements.
- Support to local soap manufacturer for products for on-farm sales (CPSR and PIF), now a growing company
- Strategies for update of labeling claims and complete CPSR for a Swedish company in discussion with MPA, everything agreed and products could remain on the market.
Nutrition and Food Supplement services
- For large established international company continuously providing support with Swedish translations and compliance with Swedish requirements
- For new start company provide support with compliance for the Nordic market