Regulatory Affairs services

We provide solutions and consultancy

AlfaNordic's Regulatory Affairs Consultants

Experience and expertise in Regulatory Affairs are fundamental to the succesful applications of marketing authorisation, marketing and maintenance of pharmaceutical products. Choose a partner with specialist knowledge to navigate the regulatory complexities within Worldwide healthcare sector. 

We delivers solutions that help you as a global life science company to manage the complexities of the regulatory environment in a global healthcare sector.

We are your partner to conduct your regulatory strategy, in order to reduce cost and increase efficiancy by maintaining quality and compliance for your products.

Regulatory Affairs - Drugs

AlfaNordic provides a full range of consulting services. We can provide:

Regulatory writing (pharmaceuticals, herbal medicines, homeopathic, consumer healthcare, etc...)

  • Product positioning and regulatory strategy
  • All Modules of the MA Dossier (CTD, EU-Nees, eCTD)
  • Literature search and documentation review
  • NonClinical Overviews, Summaries & Expert Statement (Modules 2.4, 2.6 & 4 - NCES)
  • Clinical Overviews, Summaries & Expert Statement (Modules 2.5, 2.7 & 5 - CES)
  • Technical writing and Quality Overviews
  • Writing of ASMF, DMF and CEP
  • Switch core dossier, Export
  • Drug product information: SPC, PIL
  • PSUR writing and submission, evaluation of AEs
  • Submission to the Health Authorities (National, MRP, DCP, International, etc)
  • Compilation of documentation for Marketing Authorisation
  • Preparation of Marketing Applications (New, Variations, Renewals, etc)

Regulatory maintenance

  • Compliance reviews and Deficiency reports
  • Conversion/update into CTD/eCTD7EU-Nees formates
  • Management of variations, line extensions and renewals
  • Advertising/labelling compliance
  • Proofreading and translations
  • Reimbursement/Price dossiers
  • User testing
  • Due diligence

Regulatory Affairs- Medical Devices

AlfaNordic provides a full range of consulting services for the development and registration of medical devices. We can provide:

  • Writing and evaluation of product labelling
  • Writing and evaluation of promotional material
  • Expertise in classification and evaluation of your product
  • Writing of technical dossier for Class e I, II or III medical devices according to EU current regulations
  • Notification to the competent Authority

Regulatory Affairs - Food and Food Supplements

AlfaNordic provides a full range of consulting services for the development and notification of Food and Food Supplements. We can provide:

  • Expertise in the classification
  • Evaluation of product
  • Writing of product labelling
  • Evaluation of promotional materials
  • Preparation of technical dossiers for Food and Food Supplements, according to EU current regulations
  • Notification to the Authorities.

Regulatory Affairs - Cosmetics

AlfaNordic provides a full range of consulting services for the development and notification of Cosmetics. We can provide:

  • Expertise in the evaluation of product
  • Writing of product labelling
  • Evaluation of promotional material
  • Writing of dossiers for Cosmetics including Safety reports, according to EU current regulations
  • Notification to the Authorities.

Why us?

We are a specialized consulting department within AlfaNordic, serving the pharmaceutical and biotechnology industry. We feel able to compete with companies with much bigger size for the following reasons:

Controlled growth and increasing efficiency are often the key to a company's success and profitability. These goals are just as often the company's main priorities, but can be reduced or disappear by daily disruptions of inadequate and risky processes in administration and production. As a partner, AlfaNordic will be the best within the field. We evaluate the strategic risk and provide organisational advice to the entire value chain of your company.

Our sales and delivery process

1. Competency needs

The competence requirement for the desired task is described together with the customer. Possibly a sales meeting will be held. Contact AlfaNordic Sales or a Function Manager.

2. Proposal and review

AlfaNordic prepares presentations, time requirements and CVs for the task, as well as sends the presentation to the customer and goes through it. A possible meeting for further discussion of the presentation.

3. Contract

AlfaNordic submits a contract for approval by the customer. The contract includes financial information, named consultants and time consumption, as well as start and end dates.

4. Start of task

AlfaNordic's consultants start the task at the agreed time.

5. Continuous follow-up

AlfaNordic follows up on the consultants and holds regular status meetings with both the client and the consultants.

6. Completion of task and customer evalution

The task ends at the agreed time and with the agreed price. AlfaNordic follows up with a customer evaluation form and a final dialogue with the customer.

Contact our Regulatory Affairs team

Ole Markersen
Forretningschef / Vice President
+45 3144 7511
Rasmus Kriegel
Market Director
+45 3144 7515

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