Regulatory Affairs2

Regulatory Affairs

The NIRAS’s Regulatory Affairs team (RA team) knows what it takes to obtain and maintain a marketing authorisation to sell medicinal products, herbal medicines, medical devices, and combination products.

The purpose of the Life Science industry is to help patients. However, this requires that products obtain a marketing authorisation, are marketed and maintained throughout the life cycle of the product. Marketing authorisation and product life cycle management are thus a key part of the business in Life Science, which is why it is important to have a good balance of resources and tasks.

How do you secure the right resources for life cycle management? What do you do to solve the tasks when there are resignations, illness or leave in your permanent team? Which tasks can be delegated, for example in connection with expansions of the portfolio through acquisition of products? How fast can it go? What does the process look like?

The NIRAS’s Regulatory Affairs team (RA team) knows what it takes to obtain (and maintain) a marketing authorisation to sell medicinal products (both original products and generics), herbal medicines, medical devices and combination products. We offer life cycle management as well as translation and proofreading of regulatory documents.

The Life Science industry creates products that can change peoples’ lives. But not until the products have been approved and marketed. We have the experts who can assist you with this.

Product Life Cycle Management

Registration and marketing authorisation are essential to get a product on the market. Being able to sell the product requires that it is maintained throughout its life cycle.

We handle everything from preparation of variation applications to submission of documents, to ensure that the products become and remain compliant with the regulatory requirements from the authorities. In addition, we translate regulatory documents to support products in markets world-wide.

We understand the regulatory context and the most important languages in the world.

Regulatory Affairs team collaborate across professional competencies

The Life Science industry is regulated by rules and regulatory requirements that affect many functions in a company. Therefore, Regulatory Affairs is always part of a larger context.

Our RA team understands more than their own field and collaborates widely. We know the interfaces and we relate to the professionalism of others to ensure solutions that work across all fields.

In terms of products, we are very versatile: The Regulatory Affairs team has experience with original medicinal products, generics, herbal medicines, medicinal cannabis, dietary supplements, medical devices and combination products.

NIRAS/AlfaNordic’s expertise within Regulatory Affairs

Below are the services that we offer pharma and Life Science companies within Regulatory Affairs:

Get the pharma and Life Science products on the market

  • Product classification
  • Overview of current rules and regulatory requirements for the product
  • Advice on application procedure, submission and follow-up dialogue with relevant authorities
  • Collection of relevant documentation
  • Review of dossier and feedback on application material before submission
  • Preparation and submission of applications

Product Life Cycle Management

  • Maintenance of marketing authorisations (variation submissions, follow-ups)
  • MAH transfer in connection with acquisition of products
  • Contact to relevant authorities
  • Review and update of regulatory documents - and possible translation

Particular services for generics

  • License agreements
  • Generic applications
  • Import/export of products

Get in touch

Ole Markersen

Ole Markersen

Senior Project Director

Allerød, Denmark

+45 3144 7511