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.
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 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……
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 ...…
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 ……
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……
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……
The life science industry (pharma, food, medical devices and dietary supplements) and the cosmetics industry are subject to a wide range of specific requirements from the authorities. Part of these requirements relates to production and quality management.
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.
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.
We attended the ECA conference on GMP for Cannabis in Heidelberg late October 2019 – time flies when you are busy…
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.
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.
AlfaNordic A/S is a high-end consulting house. We provide specialists for pharmaceutical production, Project Management, Management Consulting, Validation, Production Support, QA/QC, IT/Automation and Medical Devices.
AlfaNordic A/S
Lyskær 8A
DK-2730 Herlev
CVR: 31485304
Tlf.: 42 36 80 00
Mail: mail@alfanordic.com
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