Projects
Examples of projects where SRS has 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 assignments relevant to your needs.
Pharma – Regulatory affairs
- Acting as the complete regulatory affairs function for small and midsized pharma, including veterinarian companies.
- 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 start-ups, supporting the system and providing trained QA personnel to work in the system
- being part of the journey from small start ups to international companies
- Joint audits for numerous companies
- QA support as responsible person or qualified person in many companies
- Acting as local PV office managing complaints medical information, and local PV for Nordics for international company
- GDP and PV trainings
Medical device
- Taking on the role of QA/RA manager, and PRRC for small medical device companies
- Tansfer from MDD to MDR for medical device companies
- one company with +30 products in less than 6 months, including rewriting BEP, BER, CEP, CER and risk assessment. MDR certification achieved at the end of the project.
- Classification of products and proposal of regulatory strategies
- MDSAP audits
Combination products
- Development project for a new formulation of a known molecule for a mid-sized company. Covering all aspects of pharma and medical device QA and RA, including implementing design controls and QP function.
- Product development Q&RA for drug-device combination, supporing a mid-size company. Implementation of device related procedures and design controls to ensure compliance with US combination product requirements.
Cosmetics
- 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
- Continuous support with Swedish translations and compliance with Swedish and Finnish requirements for large international company
- Support with regulatory compliance for the Nordic market for start up companies