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.
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.
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.
Below are examples on types of tasks that we have solved
Get products on the market, with the help of AlfaNordic.
RA, QA og Safety
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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.