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 1359 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.
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 13485:2003 Medical devices — Quality management systems — Requirements for regulatory purposes.
Clinical Trial Supplies
Drug need interpretation, set-up, blinding and packaging operations, drug reconciliation and destruction, comparator sourcing, statistical input, supplier management
Set-up, validation and maintenance, user guidances and SOPs
GCP and Clinical Operations support
Study Drug Manual, drug accountability processes, EDC, TMF, drug sections for Clinical Study Synopsis and Protocols, IM and MM presentations