Welcome to AlfaNordic A/S - Excellence in GMP

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 pharmaceutical 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.

Courses and training

AlfaNordic offers customer-tailored education, fully up-to-date with today’s standards. We know the challenges that the Life-Science industry is facing and offer a broad range of knowledge within strategic and organisational consulting services, from risk assessment within the industry to administration, GAP quality analysis, interim management and GMP.

Project Management

Our competencies within project management cover a wide range of the pharmaceutical industry. From raw material and utility systems over filling and packing lines to complete plants manufacturing vaccine.

Medical Device

Expert knowledge and consultancy of a high quality through all phases of the life cycle of the medical equipment.

QA Services

Our QA/QC area delivers high-end services in compliance with Eudralex vol. 4 (FDA210&211), CFR 820, and ISO 13485, including all guidelines. In addition, we offer QC experts, resources for QP, QP delegates and QP assistants.

Management Consulting

Strategic and organisational consulting services. Risk assessment ranging from industry to administration. From idea to implementation.

Validation

Qualification and validation of facility, equipment, processes (API, Aseptic, Packing), cleaning validation and IT/automation. We can advise, perform reviews and quality assurance, or we can prepare the required documentation ourselves.

IT / Automation

User representatives for drawing up requirements in connection with URS documents, hardware, software, instruments, calibration, bus systems, data collection, alarm handling, validation (FAT, SAT, IQ, OQ, PQ, PV, MIT). Analyses and implementation in practice.

Production Support

Experienced resources for preparing batch documentation, non-conformities, CAPA, SOP and associated training. AlfaNordic can supply chemists and pharmacists to consult and assist in the production, as well as experienced auditors for internal audits and audits of subcontractors and CMOs.

Examples of assignments

QRM analyses (FMECA)
Risk management
Mitigation
Product recalls
Interim management
Production support
Client representative PM
QP assignments
PQ/PV & Cleaning validation
IQ, OQ, VMP, VPL, URS
Serialisations / UDI
Supplier and internal audits
Training (GMP & QRM)
Contractor & vendor sourcing
QA Assignments
QC Validation & Consulting
Audit (internal, suppliers, MOC)

Do you want to know more? Set up an introductory meeting or send us a competency request or inquiry

Contact us

Do you want to set something in motion now? Contact the sales department at AlfaNordic here

Contact us

AlfaNordic articles & news

Latest news, interviews and articles.

Permanent employment of Peter Anthonisen
7 Sep 12:43 pm

AlfaNordic welcomes Peter Anthonisen (PSA) who has been offered a permanent employment in Validation 1. of September...

Welcome to Lone Wennergaard – New employee in Project Management & Consulting
6 Jul 10:13 am

AlfaNordic welcomes Lone Wennergaard who has joined Project Management & Consulting as of 1. July. Lone is...

Welcome to Morten Lund – New employee in Project Management & Consulting
7 Jun 12:10 pm

AlfaNordic welcomes Morten Lund who has joined Project Management & Consulting as of 7 of June. Morten...

Welcome to Niels Christian Nielsen – New employee in Validation
7 Jun 12:05 pm

AlfaNordic welcomes Niels Christian Nielsen who has joined Validation as of 1 June. Niels has extensive knowledge...

Welcome to Henriette Dahlgaard – New employee in QA/QC
7 Jun 12:02 pm

AlfaNordic welcomes Henriette Dahlgaard who has joined QA/QC as of 29 May. Having more than twenty years...

Academy Kickstart
2 Dec 05:53 pm

Debriefing: Wid Talal has completed the AlfaNordic Academy boot camp. Here she talks about her experience with the...

Stuff that works – Inspired by Wolves
2 Dec 05:45 pm

Preben Werther just turned 66. He doesn’t show his age, but like he says, ”a lot of...

The ultimate strong will
2 Dec 05:31 pm

If you want to apply a label to Henrik Bjørn Linnemann, then the word “change specialist” would...

Project: Education Science
1 Jun 06:35 pm

Trine and Simone come from the programme Uddannelsesvidenskab (the Education Science programme) at the University of Århus,...

After Hour Meetings
1 Jun 06:34 pm

How do you work with the small c in front of GMP? AlfaNordic regularly organizes free inspirational...

We are looking for

We are always looking for competent consultants. See our job advertisements or send us your CV.

AlfaNordic US is now accepting CV’s/Resumes for our current and upcoming projects. Apply your CV to us@alfanordic.com.

Contact to our Directors

Contact our Directors directly if you want to know more, send us a competency inquiry or book an introductory meeting. We are ready to help you.

Frank Winther-Hinge
Management Consulting

T: +45 5059 1598

Paul Orlien
QA / QC

T: +45 5356 7700

Mai-Britt Olafsson
Validation

T: +45 5353 4378

Torben Dahlfelt
Medical Device

T: +45 2888 4060

Frank Winther-Hinge
Project Management & Process

T: +45 5059 1598

Henrik Linnemann
Senior Partner

T: +45 2811 0091

Thomas Meldgaard Petersen
Senior Partner

T: +45 4050 9300

Christian Ilsøe
Senior Partner

T: +45 5152 9030

Preben Lind Hansen
Sales

T: +45 6146 2340

Mikala Nøhr Lange
Business Support

T: +45 5353 1155

Torben Dahlfelt
IT & Automation

T: +45 2888 4060

Contact to our US Office

Contact our Directors in the US directly if you want to know more, send us a competency inquiry or book an introductory meeting. We are ready to help you.

Jim Hubbard
Dir., Business Development US

T: +1 (919) – 448 – 4843

Henrik Linnemann
Senior Partner

T: +45 2811 0091