Our goal is to assure that your quality management system matches the needs related to your activities. No more and no less.

What we do …

GMP and GDP, Pharma
GMP consulting in relation to API and Drug Product requirements in accordance with Danish executive orders 1360 and 1358, European and US requirements as outlined in ICH Q7, Eudralex Vol. 4 Part I, II and III including annexes and 21 CFR part 11, 210 and 211.

GDP Consulting in relation to Danish executive order 1541 and Guideline on Good Distribution Practice of medicinal products for human use.

Development of drug substance and drug product in relation to ICH guidance as outlined in quality guidelines Q8, Q9, Q10, Q11 and Q12.

Function as Qualified Person or Responsible Person

Pharmac is currently involved in different Cannabis Projects

Company specific courses with the area GMP and GDP

GMP, Cosmetics
Manufacturing of cosmetics according to ISO 22716:2007 Cosmetics — Good Manufacturing Practices (GMP) -Guidelines on Good Manufacturing Practices

GMP, Medical devices
Manufacturing of medical devices according to ISO 13485 Medical devices — Quality management systems — Requirements for regulatory purposes.

Pharmac has many years of auditing experience within the area of e.g. Pharmaceutical Manufacturing including sterile – non-sterile and biologics, API-manufacturing, Drug Development, GDP, Devices and Packaging materials.



Below you can find a selection of GxP related area’s in which we provide consultancy services.

Feel free to contact us if you have questions!

Quality Assurance

Quality Control

Service as Qualified Person


GMP/GDP training

System for accreditation (ISO) and internal audit

GMP/GDP – Self Inspections

Quality Risk Management

Vendor and contract manufacturing evaluation and audits

Analytical Development

Writing and review of ÍMPD/IND/DMF

Project Management

Method and Process Validation

Cleaning Validation

Equipment Qualification

CMC – Chemistry, Manufacturing and Controls

Outsourcing support

Supply Chain Management

Contact us

Feel free to send a message to pharmac@pharmac.dk if you have questions or just want to get in touch.
You are also welcome to call us on +45 2065 4919.

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