Let us help you reach ambitious goals. Together we transform rules and legal sections into practical solutions.
Achieve confidence through a consulting partner who creates overview and solutions
We help the people behind the medicine provide safe products of high quality on time.
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AlfaNordic gives advice, educates and solves tasks within Pharma, Biotech, Medical Device, Food, Cosmetics and Medicinal Cannabis.

Our professional range is wide, and our consultants have the necessary knowledge, experience and drive to create lasting solutions compliance with the requirements of the authorities and the needs of each company. 

Our consultants are available - also at short notice.

Our core competencies

Pharma

The challenges of the Pharma Industry range widely, from product development, production of high-tech pharmaceutical specialties, regulatory requirements to pharmacovigilance and reporting. 
We offer advice and practical help within…

Medical Device

Medical Device Regulation (MDR), 2017/745 comes into force 26 May 2020.
Is your business ready for May 26, 2020? We can review your quality system and…

Medicinal Cannabis

We have extensive experience with the challenges that may arise in connection with the cultivation, manufacture, import and export of medicinal cannabis and offer advice on business and product approval, including ...

Food and Food Supplements

Increasing regulatory requirements for the production and marketing of Food / Food Supplements have gradually led to a regulatory complex that makes it complicated for businesses to comply with the legislation.
 
We can help create an overview or review / develop quality systems to meet the requirements of the authorities …

Cosmetic

Which rules apply to cosmetic products? The cosmetics regulation 1223/2009 must be obeyed. This means, for example that cosmetic products must be manufactured in accordance with good manufacturing practices and must be reported in the EU Cosmetics Database (CPNP).
Our consultants are ready to help you…

Courses and training

We specialise in education and competency development and believe that education and development of people is the way to a better future.

AlfaNordic Academy A/S is a strategic supplier of courses and talents for leading Danish and international companies in the life science industry…

Latest news

Build GMP into your facility from the start with an owner consultant

In this article you can read about how an independent owner consultant can create value. Especially through assessment of the enterprise and through continuous monitoring of the progress. This is interesting if you are responsible for expanding a production, for new GMP facilities, or have an enterprise task to be solved. Especially if you do not have an established project organisation or project execution model.

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The consultancy A-consult lives on in a professionally strengthened AlfaNordic

After 35 years as an independent consultancy, A-consult opens a new chapter at the start of 2020, together with AlfaNordic: Since June 2018, when AlfaNordic bought A-consult, the two consultancy have gradually worked closer together by sharing knowledge, consultants and experience. From 1st January, 2020, they will also share their names as the collaboration continues under AlfaNordic A/S.

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Learnings from an Organisational project

Changing infrastructure in busy organizations can be a complex task. Understanding the limitations, opportunities and finding a solution best suited for all the involved departments and colleagues is challenging. Especially for business critical processes, the ability to make the right decisions is crucial for the future of the business. This article will highlight some of the challenges our consultants experiences and is a window into our processes and results.

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How can the life science industry meet the authority requirements for risk analysis and management?

We have more than 10 years' experience with GMP services for the life science industry, including how to interpret authority requirements in relation to the implementation of Quality Risk Management (ICH Q9) and quality risk management as part of the company's risk assessment . We want to be the leading consultants and have performed many risk analysis projects since ICH published Q9 in 2006.

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New validation package which ensures cost-effective validation of temperature-controlled facilities

Validation of temperature-controlled facilities and equipment may be seen as a time-consuming task for experts. However, it is necessary according to current requirements – and this means that new ways of thinking must be applied by maintaining the high quality, which ensures that the product has been manufactured and stored under the right conditions and that the company is in compliance with current guidelines.
and the company is in compliance with the applicable guidelines.

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