Interim Quality Management & Locum Services
Qualified Person (QP) services for batch release of both commercial products according to Directive 2001/83/EC and investigational medicinal products (IMP) according to Directive 2001/20/EC. This is offered on an interim or contract basis depending on the client’s QP requirements e.g. as a backup QP to cover your own QP’s absence or as interim Head of Quality during recruitment.
Responsible Person (RP) services for businesses holding Wholesale Dealers Authorisations (Human) (WDAH) to comply with the prevailing requirements of Good Distribution Practice (GDP).
We can set up and carry out Good Manufacturing Practice (GMP) audits of client subcontractors e.g. with contract manufacturers or packers, analytical laboratories including Active Pharmaceutical Ingredient (API) suppliers. Wide experience has been obtained in auditing companies across Europe and the Asia/Pacific region.
Regulatory Inspections & Regulatory Affairs
Assisting companies in the preparation for GMP inspections by the Health Authorities with specific experience of the UK’s MHRA and Ireland’s IMB. Support would be given e.g. with a Gap Analysis and assistance as required with procedures, protocols and reports.
Review of Module 3 (Quality section) for Marketing Authorisation Applications to the national or European agencies.