Welcome to AlfaNordic A/S - Excellence in GMP

About us

A house full of competencies

Who are we?

Get to know us quickly

AlfaNordic A/S is a high-end consulting house with more than 60 employees working in the life science industry. We are specialists in pharmaceutical production, project management, management consulting, validation, production support, IT/AUT, QA/QC and medical device.

Our consultants work as user representatives in projects, as technical experts and in productions within the industry, in Denmark as well as internationally. We have framework agreements with a large part of the pharmaceutical manufacturers in Denmark.

Why choose us?

We have competitive edge and perform at our best for our customers.

  • Solid experience

    We have solid experience within the biotech and Life Science industry. A big part of our expertise stems from collaboration with the 10 biggest biotech and pharma companies in Denmark, and most of our consultants have worked in the industry for many years and have in-depth knowledge of production in the industry.

  • We are supported by our large network

    We work independently, but as a team. Knowledge-sharing has a high priority. Our consultants always bring our large network to the table so that when you hire a consultant through AlfaNordic you don’t just gain one more head to help solve the task. Our consultants always bring solid knowledge from our large network with them.

  • The perfect match

    We always deliver the best people for the task. We use our extensive network of Danish and international consultants. The perfect match is always our highest priority.

  • Always up-to-date

    We offer training and education within GMP and Risk Management (ICH Q9). Needless to say, our consultants continuously go through training themselves and are always up-to-date.

Our competencies

An overview of our business areas

Production Support

AlfaNordic can step in and provide production/maintenance people. AlfaNordic have pharmacists and engineers with production experience who can prepare non-conformities, CAPAs, SOPs and handle batch documentation.

Preben Lind Hansen
Business Development

T: +45 6146 2340

Management Consulting

AlfaNordic provides consultancy services within GMP compliance, GAP analyses, LEAN, optimisation and other areas. Based on work with different customers, AlfaNordic has solid experience with high-end compliance and optimisation consultancy as well as systems for systematic risk assessment (ICH Q9).

Frank Winther-Hinge
Managing Director, AlfaNordic Academy

T: +45 5059 1598

Validation services

We perform validation of process equipment, utilities and other equipment. Our consultants have gained wide experience in a variety of roles from large and small projects. We take on validation management/coordination in green field projects and smaller reconstructions. Our primary areas are cleaning validation, PQ and PV, protocol preparation, execution and reporting.

Mai-Britt Olafsson
Validation

T: +45 5353 4378

QA / QC Support

We can step in with a number of experienced consultants and solve tasks and projects that our customers may not have time to handle in their everyday activities or which require a high degree of competency and experience.

We provide assistance with everything from approval to release of documentation, validation and development of test methods. Audits play a big part of our services and we have a great many QP resources at our disposal.

Paul Orlien
QA / QC

T: +45 5356 7700

Project management and process

AlfaNordic can provide experienced project managers. This may be to support a customer or to solve concrete projects under the customer’s auspices. AlfaNordic also possesses a number of competencies within the process area and general engineering.

Frank Winther-Hinge
Managing Director, AlfaNordic Academy

T: +45 5059 1598

IT & Automation

AlfaNordic performs assessments of computer systems with a view to establishing compliance status, including GAP analyses, risk assessments and other services. We furthermore perform validation of IT and automation systems.

Maria Sloth Brendstrup
Consultant Manager

T: +45 3144 7539

Medical Device

AlfaNordic performs mock inspections and internal inspections. We perform validation of processes and systems. In addition, AlfaNordic provides consulting services in connection with risk assessments, GMP and challenges within quality systems.

Charlotte Borgensgaard
Medical Device

T: +45 3144 7541

AlfaNordic West Sealand

AlfaNordic West Sealand is a department of AlfaNordic in Kalundborg. The department was established in 2018 with the aim of better servicing customers outside the metropolitan area. AlfaNordic West Sealand also facilitate inspiration meetings in Kalundborg on a regular basis.

Bettina Clement Christoffersen
Consultant

T: +45 3144 7501

AlfaNordic Facts

Employees

Consultant assignments in 2016

Growth in % (2015-2016)

Km on the road in 2016

Our history

Briefly

AlfaNordic was founded in Denmark in 2008. From the start, focus has been on delivering quality and validation services and project management services to the pharmaceutical industry. We work with our customers within the existing production as well as in the role of customer advisor in projects associated with establishment of new plants or expansion of existing plants. We offer validation and qualification support on everything from the individual piece of equipment to entire plants. Beyond that, we have strong competencies within project management, production, QA, QC, Management Consulting, Medical Devices, audits of processes and manufacturers and training and education of personnel within a number of competency areas.

In 2009, we decided to be present in China, to be in a position to provide better services to our customers who are already operating in China and to customers who have plans of exporting to Asia or establishing new facilities in the Far East.

Today, we do business with almost all the large pharmaceutical manufacturers in Denmark and we are perceived as a leading supplier of services at a high professional level. In addition, we are also engaged in several international consulting assignments.

In 2013, AlfaNordic was turned into a joint-stock company with a professional board of directors.

In 2016 we moved into our headquarters on Lyskaer in Herlev and the US office in North Carolina was established.