flag

CHOOSE COUNTRY

Regulatory Services

Regulatory affairs

Management team at PharmaRelations

We tailor the solutions to meet your needs

As a trusted Nordic regulatory affairs partner, we provide expert support in regulatory due diligence, gap analyses, and market entry strategies. Our services include preparing product information in local languages for regulatory submissions, supporting product launches, and offering medical information services.

We specialize in developing tailored regulatory strategies, ensuring compliance, and guiding clients through regulatory processes. Our expertise covers regulatory opportunities, risk assessments, and operational aspects to help businesses navigate complex compliance requirements efficiently.

Testimonial

As a newly established Nordic CNS Specialty Pharmaceutical Company, with a strong European history and presence, we looked for a trusted, experienced and talented partner with a similar growth mentality. And having selected PharmaRelations from “Day 1” they have met with and vastly exceeded our expectations. Their deep & broad expertise in Regulatory Affairs and Quality Assurance, combined with their tailored and proactive approach, has been invaluable in navigating the business critical regulatory and quality requirements in the Nordics and in creating and improving our internal processes. Their ability to respond on short notice as well as being proactive has been their contribution to making our journey a success. We highly recommend PharmaRelations to any organization seeking reliable and professional Regulatory Affairs and Quality Assurance support!

/Magnus Wassen, General Manager Nordics, Neuraxpharm

Job interview in Life Science

OUR TEAM

We provide a wide range of Regulatory Affairs consulting services.

NORDIC REGULATORY AFFAIRS

We are specialists in regulatory affairs activities in the Nordic region, with a deep knowledge of the local regulations. Our employees operate locally with clients and regulatory agencies, ensuring seamless cross-country collaboration.

PRE-APPROVAL REGULATORY AFFAIRS

We help you prepare a solid and feasible regulatory strategy, which is aligned with your clinical development plan and addresses relevant regulatory risks. We provide hands-on support with executing your plan.

MARKETING AUTHORIZATION

We are your partner for preparing and executing regulatory strategies. We help you optimize the value of your product pipeline through efficient regulatory affairs project management, ensuring timely submissions of high-quality documents.

FOOD SUPPLEMENTS & FOOD

The requirement on food and food supplements differs in the Nordic countries. There are local regulations and EU legislation that you need to consider before placing your product on the specific market. We can help you with this.

COSMETICS​

The cosmetic industry follows the cosmetic regulation and all products needs to be registered in the CPNP. How can we help you?

Clinical experts in sponsor oversight

Why Choose PharmaRelations?

When it comes to regulatory affairs in the pharmaceutical industry, you need more than just a consultant, you need a trusted partner who understands both the regulatory landscape and the dynamics of the market.

Strong local presence across the Nordic region

Our dedicated teams operate across Sweden, Denmark, Norway, and Finland, ensuring tailored regulatory solutions that align with local requirements. We offer hands-on support, leveraging deep regional expertise to help clients successfully navigate the Nordic market.

Extensive knowledge about Nordic regulations and market dynamics

With years of experience in the pharmaceutical sector, we provide insights into evolving regulatory landscapes, trends, and compliance challenges. Our expertise enables clients to meet regulatory expectations efficiently while maximizing market potential.

Experienced team with knowledge about the entire product life cycle

Our specialists guide clients through every stage, from clinical stage activities to marketing authorization and post-approval compliance. We ensure smooth transitions across regulatory milestones, mitigating risks and optimizing timelines.

Local focus – global reach

While we specialize in the Nordic region, our expertise extends to European and US regulatory frameworks. We assist clients in meeting international standards, facilitating market entry and compliance in highly regulated global markets.

Operational excellence delivered in a timely manner

We prioritize efficiency without compromising quality, streamlining regulatory processes to reduce delays and enhance market readiness. Our proactive approach ensures clients receive timely, strategic support tailored to their needs.

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

Computer with excel screen


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.

Cookies