We are committed to responsibility...
Diapharm provides information officers, qualified persons for pharmacovigilance (QPPVs) and qualified persons (QPs), and it can act as a manufacturer. Long term or short term.
... in legally prescribed roles
Marketing authorisation holders and pharmaceutical companies are required to fill certain positions at their companies with employees who have precisely defined qualifications. One of these positions is the QPPV, who is responsible for the constant monitoring of drug safety. Companies are also responsible for naming an information officer, who ensures that the information contained in summaries of product characteristics and advertising complies with the information outlined in the marketing authorisation documents. And then there is the Qualified Person or QP, who is responsible for compliance with pharmaceutical regulations regarding manufacturing, testing and release. Some of these people even need to be available 24/7, resulting in staffing challenges for companies.
We shoulder the responsibility that comes along with these legal requirements in accordance with Directives 2001/83/EC (Medicinal Products for Human Use) and 93/42/EEC (Medical Devices Directive; MDD). Short term – to fill in for staff on holiday/PTO leave or to bridge the gap left behind when employees leave the company – or long term.
... as manufacturer for batch release
Diapharm goes one step further: on request, we will take direct responsibility for medicinal products by acting in a number of roles, including “releasing manufacturer” for medicinal products and investigational medicinal products. Diapharm’s QPs can take care of batch release and/or EU import release. A number of different kinds of companies take advantage of this service, including:
- Sales and marketing companies that do not want to maintain their own structures for quality assurance and release in accordance with EU GMP guidelines
- Companies from non-EU states that want to import medicinal products or active substances requiring authorisation
- Contract manufacturers that do not want to bear the responsibility themselves for overall release
We ensure that authorised medicinal products manufactured in compliance with GMP guidelines are marketable. Contact us!
Did you know? We also “hold” existing marketing authorisations on behalf of the pharmaceutical industry in our role as marketing authorisation holder.