REGULATORY AFFAIRS

Get you products on the market, without trouble.

To help patients is the main goal of the life science industry. To obtain this, demands that a product; obtains marketing authorisation approval by the authorities, gets properly on the market, and keeps being maintained. The marketing authorisation and the product life cycle management are therefore important factors within the business of the life science industry. As to why it is also important with a good balance in resources and tasks.

How do you ensure that you have the right resources for life cycle management? What do you do, when someone in the team resigns, gets ill or takes a leave? Which tasks can be delegated in the team, as an example in the process regarding the expansion of the portfolio through business deal of a product? How fast can it go? How does the process look?

AlfaNordic’s Regulatory Affairs team (RA-team) knows what it takes to obtain (and maintain) the authorisation to sell pharmaceutical products (both original preparations and generics), herbal remedies, Medical Device, We offer life cycle management, translation and proof reading of regulatory documents. 

The life science industry creates products, which can change people’s lives. This will only happen when the products reach the market. Get your products on the market, with the help of AlfaNordic.

PRODUCT LIFE CYCLE MANAGEMENT

Registration and marketing authorisation is crucial when it comes to get a product on the market. To be able to sell products demands lifelong maintenance.

We will handle everything, from the composition of variation applications to the submission of documents, to ensure that the products are and remain in compliance with the regulatory requirements from the authorities. We also translate regulatory documents, which supports products in the whole world.

We understand the regulatory context and 238 languages.

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ACROSS COLLABORATION

The Life Science Industry is regulated by rules and authority requirements, which impacts a lot of factors in a company. Regulatory Affairs are therefore always a part of a bigger comprehension.

Our RA-team understands more than their own expertise field and are excellent in collaborating. We know of interfaces and speak into others´ technical terminology, to make sure that we find solutions which function across.

Product-wise we also embrace a lot of different areas: The Regulatory Affairs team has experience with original pharmaceutical products, generics, herbal remedies, medical cannabis, daily supplements, medical devices and combining-products.

ALFANORDIC REGULATORY INTELLIGENCE REPORT

Do you want an overview of what is new in RA? Then get the AlfaNordics Regulatory Intelligence Report every month. It's completely free. All you have to do is fill out the form below. 

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OUR EXPERTISE WITHIN REGULATORY AFFAIRS

Below are examples on types of tasks that we have solved

GET ON THE MARKET

  • Product classification
  • Overview of current rules and authority requirements for products
  • Advice on the application procedure, submission, and follow-up dialogues with relevant authorities
  • Collecting relevant documentation
  • Review of dossier and feedback on application materials before submission
  • Composing and submitting applications.

PRODUCT LIFE CYCLE MANAGEMENT

  • Maintenance of marketing authorisation (variation submissions, follow-ups).
  • MAH transfer regarding acquisition of products.
  • Contact to relevant authorities.
  • Reviewing and updating regulatory documents  – translating, if necessary.

PARTICULAR FOR GENERICS

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

LET US REACH THE GOALS TOGETHER

Let's talk about your company and the possibilities for a possible Cooperation. 

CONTACT US ABOUT REGULATORY AFFAIRS

Get products on the market, with the help of AlfaNordic.

Ole Markersen

Vice President

Subject areas
Medical Device
Cosmetics
RA, QA og Safety 

+45 31 44 75 11
OLM@alfanordic.com

Lisbeth Bonde

Business Developer

Subject areas
Customer contact
Propositions and contracts
Follow-ups

+45 31 44 75 44
LIBO@alfanordic.com

LET'S GET STARTED

BOOK A CONSULTATION, FREE OF CHARGE 

Are you ready for changes? Let us talk about your company’s ambitions and how we can break through in a new country.

Get an idea of what we can offer, by participating in our inspiration meetings. Here our specialists share their knowledge and experiences.

MEET OUR SPECIALISTS - PARTICIPATE IN OUR INSPIRATIONAL MEETINGS

CONTACT US

Do you have any questions, or do you want to know more? Contact us. You can find our contact information below. We look forward to hearing from you.

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