Qualified Person and Responsible Person Services
We have several highly experienced QPs with knowledge of a wide range of dosage forms and processes such as:
- Capsules, both hard and soft shell
- Liquids, creams and ointments, both sterile and non-sterile
- Sterilisation by filtration, irradiation and ethylene oxide
- API supplier auditing, both small and large molecule to EU GMP Part II/ ICH Q7
- Excipient supplier auditing to IPEC-PQG guidelines
- Packaging supplies auditing, covering leaflets, labels, cartons, foils & films, primary containers to GMP and PS9000:2016
- Contract analytical laboratory auditing to GMP and ISO 17025:2017
- Storage and distribution warehouse auditing to GDP
- Supply chain mapping and risk assessment thereof to comply with the Falsified Medicines Directive 2011/62/EU
Release of finished products onto the market
Our team of experienced QPs can act as contractors named on your or a third parties Manufacturers Import Authorisation for both human and veterinary medicines under European Directives 2001/83/EC and 2001/82/EC to facilitate release of your products to the EU market. Our QPs can also provide audits and assessments in relation to your supply chain.
Responsible person services for wholesaling of medicinal products and Active Pharmaceutical Ingredients under GDP
Our highly experienced QPs can act as contractors named on your or a third parties Wholesale Dealers Authorisation for both human and veterinary medicines under European Guidelines 2013/C 343/01 human medicines and 2015/C 95/01 API’s for medicinal products for human use.
Quality defects and product recalls
We can help to investigate your product complaints to establish their root cause and ensure that appropriate corrective and preventative actions are implemented to ensure they do not occur again.
Should you be in the unfortunate position of having a product recall we can advise and support you with your interaction with the respective national regulatory agencies.