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

Medical device

  • 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

Combination products

  • 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