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.

Audits
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.