Investigational Medicinal Products
Our business unit PharmLink Consultants has been offering since 1989 (thus already before PharmDev Innovations was founded) result oriented and competence based consulting services in the field of clinical supplies, pharmaceutical development and GMP compliance.
Our service Offering has thus been both, multifaceted (covering all aspects of clinical supplies) and though focussed (since concentrated on clinical supplies).
Our way of working within consulting projects is differing a bit from the usual.
Situation has got more and more difficult since 1989:
- Needs for "Time to market" have changed.
- Communication between IMP "customers" (mostly represented by clinical research) and IMP -"providers" has become more and more difficult also due to increasing internationalisation of global clinical studies.
- regulatory envirnment (e.g. child-safety, GCP directive and regulations, Annex 13, import constraints, Qualified Person related issues) has been becoming increasingly stringent.
- Call for outsourcing also in the field of IMP provision is getting louder and louder. However, pitfalls and potentials are frequently wrongly estimated.
- Managing interfaces between involved parties is getting inreasing importance
Pharmaceutical industry and its experts in the field have been busy for years to correctly apply regulatory requirements for labelling of investigational medicinal products in practice .
In this context already the first version of EU GMP Annex 13 caused numerous discussions about practical applicability in detail.
Also the relevant GCP guidelines have contained some aspects of labelling until today.
Nowadays a lot of discussions are running caused by the respective wording in the new GCP regulation to be applied from 2016.