Medical and regulatory affairs services in the Nordics

Medical and scientific affairs support

Our Medical and Scientific Affairs services help you manage compliance and medical review tasks efficiently, without adding complexity to your operations. We support pharmaceutical companies across the Nordic countries with assignments such as:

• Compliance review and medical approval of promotional and educational materials for:
• Prescription (Rx) and over-the-counter (OTC) medicines
• Food supplements
• Medical devices
• Cosmetics
• Abbreviated product information texts
• Medical review of product information texts
• Creation of medical materials for healthcare professionals and patients, including website content
• Medical translations into all Nordic languages
• Support with all tasks related to Medical Affairs, such as:
• Preparing meeting minutes and summaries for Advisory Board meetings
• Supporting at conference booths or stands
• Providing fully outsourced Medical Experts (e.g. MSL, Medical Advisor, Regulatory/Medical Compliance Manager)
• Training tailored to your needs, such as compliance training or specialist courses in areas like pharmacology or food supplements

From single projects to fully outsourced Medical Affairs tasks, we can provide expertise at short notice while maintaining high quality.

Regulatory Affairs and Quality Assurance – comprehensive services

Our service-oriented Regulatory Affairs Specialists provide high-quality support for pharmaceutical companies throughout the life cycle of human and veterinary medicines. We also have strong expertise in the regulations concerning non-medicinal products.

We understand that companies often face tight schedules. We can support you with all assignments related to Regulatory Affairs in the Nordic countries, including but not limited to:

Regulatory affairs for medicines

• Marketing authorisation applications and maintenance (e.g. variations, renewal applications, transfer of marketing authorisations, OTC applications) for human and veterinary medicines
• Preparing, translating and updating product information texts (SmPCs, PLs, labelling) and patient support materials
• Abbreviated product information texts
• Medical translations
• Updating pharmaceutical databases (e.g. Pharmaca Fennica, Lääkeohje, FASS, Felleskatalogen, DKMAnet)
• Pharmaceutical chemical expert services (e.g. writing and updating module 2.3 and 3 texts, IMPD documentation)
• Market and shortage notifications

Regulatory affairs for non-medicinal products

• Packaging texts and registrations/notifications in accordance with local requirements
• Food supplements
• Medical devices
• Cosmetics

Regulatory CMC support

For small molecules and biological medicinal products (stand-alone and combination products, complex generics), pre- and post-approval, for European markets (Nordics, Central and Eastern Europe), as well as MENA, US, Canada, South America, Australia and ASEAN markets:

• Regulatory strategies for straightforward and complex situations
• Life-cycle management (MAA, variations, commitments, line extensions, dossier management, technical writing)
• Technology transfers (strategic support, project management, technical support)
• Due diligence (before acquisitions of pharmaceutical companies or portfolios)
• Organic chemistry problem-solving (synthesis issues, impurity assessments)
• Bioequivalence waivers or study set-ups (strategic support, project management)
• Analytical methods (method development support, problem-solving)
• Stability studies (strategies, problem-solving)
• Monitoring of evolving EU and EMA regulations

Training and compliance

• 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

• Life-cycle assessments for APIs and excipients
• Green chemistry methodologies for process development
• Environmental risk assessments (ERA) for pharmaceutical products
• Due diligence related to environmental regulations (EU Green Deal, REACH, ERA)

Quality assurance (QA)

Our experienced Quality Specialists can support you with all assignments related to Quality Assurance in the Nordic countries, including:

• Acting as Responsible Persons for the Nordics
• Establishing and managing a Quality Management System (QMS) and other GDP requirements
• Product complaint handling
• Inspection readiness support
• Market and shortage notifications

From single projects to fully outsourced Regulatory Affairs and Quality Assurance tasks – even at short notice, without compromising on quality.