AlfaNordic tilbyder Regulatory Affairs rådgivning og praktisk hjælp

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:

We combine sound management consulting with in-depth pharmaceutical and biotechnology expertise, built up over many years of industry experience.
We hire talented people who are capable of keeping several balls in the air at the same time. Quality, swiftness and execution are key words to ensure an effective way of working, whether as a participant across teams or as a senior management consultant.
We promote professional and personal development and strive to make talented people even better.

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

Director, Medical Device, Quality Assurance, Regulatory Affairs & Pharmacovigilance

+45 3144 7511

Rasmus Kriegel

Partner, Sales

+45 3144 7515