Regulatory affairs

Nordic Regulatory Affairs

Commercial expert recruitment team for Pharmaceuticals

Pre-Approval Regulatory Affairs

At PharmaRelations, we support companies in developing robust regulatory strategies to navigate the complex global landscape. Our experts help you engage with regulatory authorities, advance your clinical pipeline, and optimize the value of your assets. By providing strategic guidance throughout the development phases, we help minimize regulatory risks and accelerate your path to market.

Beatrice Öström and Sponsor oversight expert

Our Services

  • Regulatory strategy
  • Regulatory agency interactions
  • US IND
  • Clinical trial applications (incl. CTIS)
  • US Fast Track/Breakthrough Therapy Designation
  • EU PRIME
  • Paediatric investigational plan (PIP/PSP)
  • Orphan Drug Designation (ODD)
  • Clinical trial strategies and protocols
  • CMC strategy and documents
  • Pre-clinical strategy and documents
  • Regulatory writing and project management
  • Regulatory intelligence

Women experts in pre-clinical studies

SERVICES

  • Labelling
  • Review of ingredient lists
  • Claims and compliance
  • Notification in the European CPNP database (Cosmetic Product Notification Portal)
  • PIF (Product Information File)
  • Safety assessment and compilation of safety reports (CPSR – Cosmetic Product Safety Report) 
  • Prepare and quality assure the product information file (PIF) 
  • Cosmetovigilance
  • Cosmetics Good Manufacturing Practice (GMP), audit and advise

Data analyst in front of computer

FOOD SUPPLEMENTS

  • Regulatory support
  • EU legislation
  • Nutrition and health claims
  • Ingredients
  • Notification and registration of products in the EU
  • Labelling
  • Marketing compliance
  • Fortification
  • Novel Food
  • Extracts

Two consultant managers in Life Science

Marketing Compliance

Navigating the landscape of pharmaceutical compliance requires a deep understanding of international, European, and local laws, regulations, and ethical guidelines. With our team of experts from the Nordic countries, we bring knowledge and experience to your business.

We specialize in guiding companies in the Nordic region through the intricate web of ethical regulations. Whether you’re launching a new product, planning an event, or reviewing your advertising campaigns, we provide the strategic advice you need to ensure your activities are fully compliant.

Key Areas of Expertise:

• International, European, and Nordic pharmaceutical regulations
• Local market expertise in Sweden, Norway, Denmark and Finland
• Pharmaceutical industry best practices and processes


Beatrice Öström and Sponsor oversight expert

OUR SERVICES: COMPREHENSIVE COMPLIANCE SOLUTIONS

We offer a wide range of services designed to support your pharmaceutical business in maintaining compliance across all marketing and promotional activities. Our flexible, ad-hoc approach means we can quickly adapt to your needs, whether you require ongoing compliance support or short-term project-based assistance. From conferences to product information meetings and materials, we provide guidance. We help ensure that your interactions with healthcare professionals and other stakeholders meet ethical standards.

We can also provide tailored training programs to equip your team with the latest knowledge on pharmaceutical marketing compliance. Whether you need a workshop on the local rules in each Nordic country or broader European regulations, we can help you stay ahead of the curve.

PharmaRelations logo wall

We meticulously review and approve promotional materials on a per-project basis, ensuring precision and alignment with your goals.

Outsource the entire approval of promotional material to our experts, granting you the freedom to concentrate on more strategic aspects of your business.

Life Science consultant concentrated

OUR SERVICES: TAILORED TO YOUR NEEDS

Compliance is not a one-size-fits-all solution, and we recognize that every business has unique needs. We tailor our services to fit your specific goals, ensuring that you receive the most relevant and effective solutions.

Here are examples of what we can offer:

• Compliance with local industry regulations: Swedish LER, Danish ENLI, Norwegian LMI, and Finnish PIF Code of Ethics, European Federation of Pharmaceutical Industries and Associations (EFPIA) as well as  local medicinal products acts
• Review and approval of marketing materials (Rx and OTC)
• Risk assessment for promotional campaigns
• Digital and social media compliance guidance
• Event and sponsorship
• Support for international congresses hosted in the Nordics
• Advice and support on activities with Healthcare Professionals  (HCP)/ Healthcare Organizations (HCO)/Patient organizations and politicians
• Reporting and documentation
• Compliance processes and systems audits and revisions
• Training and workshops on compliance

One woman two men having a meeting discussion

WHY CHOOSE PHARMARELATIONS?

When it comes to marketing compliance in the pharmaceutical industry, you need more than just a consultant, you need a trusted partner who understands both the legal landscape and the nuances of the market.


Local Expertise in a Nordic organization

With compliance experts across the Nordic countries, we offer localized knowledge, ensuring that your activities remain compliant in every market you serve.


Flexibility and Agility

We understand that compliance needs can vary from one project to the next. Whether you're seeking one-off advice or ongoing strategic support, we provide flexible, ad-hoc solutions that align with your needs and timelines.

End-to-End Compliance Support

From initial product launch to ongoing marketing efforts, we provide compliance support for all aspects of pharmaceutical marketing.

Let us guide you through the complexities of the Nordic market and help you achieve your goals with confidence.

Computer with excel screen


PHARMARELATIONS2025-0238

Marketing Authorization

We provide end-to-end regulatory support, ensuring compliance, efficiency and market access across the Nordic region and beyond. With deep expertise in regulatory frameworks, we streamline processes, manage interactions with authorities, and facilitate product approvals and lifecycle management. Our multilingual capabilities and strategic insights help clients navigate complex regulatory landscapes with confidence, enabling successful product launches, expansions, and ongoing compliance.

Beatrice Öström and Sponsor oversight expert

Our Services:

  • New Marketing Authorisation Applications (MAA)
  • Maintenance of Marketing Authorisations 
  • Update and translations of local language materials to and from all Nordic languages (Swedish, Danish, Norwegian, Finnish, Icelandic):
    • Product information (SmPC
    • PIL, labelling)Artworks and mock-ups
    • Educational material
    • Marketing material
  • MRP/DCP/national and centralized procedure
  • Regulatory agency interactions
  • CMC (variation assessments and documentation)
  • Variations, renewals, article 61(3) notifications, MAH transfers
  • OTC Switch applications (Rx to OTC)
  • Geographical expansion
  • Regulatory project management
  • Regulatory intelligence
  • Due diligence
  • eCTD

Commercial Consultant Manager PharmaRelations

NORDIC EXPERTS IN REGULATORY AFFAIRS

With extensive knowledge of Nordic regulations and market dynamics, PharmaRelations is your trusted partner for navigating complex Regulatory Affairs challenges across Sweden, Denmark, Norway, and Finland. Our team brings valuable experience from the pharmaceutical industry as well as regulatory agencies, ensuring comprehensive support for your compliance and market access needs.

Medical writing services for Life Science team

Our Services:

  • Nordic Regulatory Affairs Partner
  • Local regulatory strategies 
  • Expert advice on national legislation and requirements
  • Regulatory agency interactions
  • Launch activities 
  • 1st line medical information
  • Update and translations of local language materials to and from all Nordic languages (Swedish, Danish, Norwegian, Finnish, Icelandic):
    • Product information (SmPC, PIL, labelling)
    • Artworks and mock-ups
    • Educational material
    • Marketing material
  • Catalogue texts (FASS, Felleskatalogen, DKMAnet, PharmacaHub)

Cookies

This website use cookiesfor statistic and user experience.

Pharmarelations uses cookies to improve your user experience, to give basis for improvement and further development of the website and to be able to direct more relevant offers to you. Please read our personal data policy. If you agree to our use, select Allow All. If you want to change your choice afterwards, you will find that option at the bottom of the page.