Regulatory Affairs and Quality – comprehensive services in the Nordic countries

Do you need a Nordic Regulatory Expert? Our service-oriented Regulatory Affairs Specialists are here to help you throughout the life cycle of human and veterinary medicines. We know that you often face challenging schedules, and we are ready to help you even at short notice without making compromises on quality. From single projects to fully outsourced activities – please contact us for further information!

• Marketing authorisation applications and maintenance (e.g. variations, renewal applications, applications for transfer of a marketing authorisation to a new holder and OTC applications) for human and veterinary medicines
• Preparing, translating and updating product information texts (SmPCs, PLs and labelling) and patient support materials
• Updating pharmaceutical databases (e.g. Pharmaca Fennica, Lääkeohje, FASS, Felleskatalogen)
• Pharmaceutical chemical expert services (e.g. writing and updating module 2.3 and 3 texts and IMPD documentation)
• Regulatory review of texts related to herbal products, dietary supplements, cosmetic products and medical devices
• Introduction to market and shortage notifications
• Handling of product complaints, QA tasks

Full regulatory CMC support for small molecules and biological drug products (stand-alone and combination products, complex generic products)  

Pre- and post-approval, for European markets (Nordics, Central- and Eastern Europe), as well as MENA, US, Canada, South America, Australia, ASEAN markets. 

Areas we can support: 

• Regulatory strategies for straight-forward and complex situations  
• Life-Cycle Management (MAA, variations, commitments, line-extensions, dossier management, technical writing) 
• Tech Transfers (strategic support, project management, technical support) 
• Due Diligence (full support before acquisitions of pharmaceutical companies or portfolios) 
• Organic chemistry problem solving (synthesis problem solving, impurity assessments) 
• Bioequivalence waivers or study set-ups (strategic support, project management) 
• Analytical methods (support for method development, problem solving)  
• Stability studies (strategies, problem solving) 

Monitoring of Evolving EU Regulations 

Keeping up with evolving EMA pharmaceuticals regulations  

Areas we can support: 

• Training and workshops on new EMA guidelines. 
• Compliance strategies for updated GMP and GLP requirements. 
• Support for implementing ICH Q12 guidelines: Product Lifecycle Management, Post-Approval Change Management Protocols, Established Conditions and more 

Sustainability and Green Chemistry  

Increasing focus on sustainability for companies to align with EU Green Deal (Climate Neutrality 2050) and other environmental regulations (REACH, ERA)  

Areas we can support: 

• Life-cycle assessments for APIs and excipients  
• Green chemistry methodologies for process development 
• Environmental risk assessments (ERA) of pharmaceutical products 
• Due Diligence