UK firm has four European QPs on site at Nottingham plant
UK pharmaceutical manufacturer Aesica is helping clients to reach EU Clinical Trials through its on-site Qualified Person (QP) service.
Aesica has four highly trained and qualified European QPs at its site in Nottingham, who routinely release clinical trial supplies into clinics across the EU.
Due to Aesica’s experience and established processes, the team can also provide QP EU release as a service for clinical trial products that have been manufactured in a non-EU country. As a result, US pharmaceutical companies are choosing to partner Aesica for the release of non-EU manufactured clinical trial supplies into the UK and other European countries.
Aesica’s onsite facilities in Nottingham include GMP analytical laboratories with the capability for full specification testing and can accommodate various dosage forms including oral, topical, inhaled and parenteral products. Most importantly, Aesica is able to provide the certification required for clinical trial supplies to be used at EU trial sites.
Paul Titley, managing director, R5 Formulation Development, Aesica, said: ‘Aesica’s Nottingham site employs 60 people and it is quite unique for a unit of our size to have so many QPs on site, which gives us a real advantage in the marketplace. We’ve recently delivered a series of successful contracts for American clients and our partners appreciate the ease and efficiency of having our QP on site at all times, as we’re not reliant on sub-contractors and are therefore able to respond to client requirements quickly and effectively.
‘As the QPs regularly release clinical trial materials for projects in the EU they are fully aware of industry processes and regulations and have the benefit of being able to discuss projects with each other on site. As with all other services at Aesica, we offer an effective, personalised and reliable service that enables new products to enter the EU clinical trial stage as quickly as possible.’
Aesica’s R5 Formulation Development business unit develops and manufactures new medicines and clinical trial materials and is a leading provider of pharmaceutical dosage form development across Europe. It provides formulation development, analytics and GMP services and guides clients through the processes of new medicine and material development for Phase I and Phase II clinical trials, maximising budget effectiveness by minimising experimentation without sacrificing quality levels.
Aesica is a leading full-service provider of contract research, development and manufacturing services for formulated products and active pharmaceutical ingredients. The company develops long-term strategic partnerships with its clients, responds quickly and effectively to market demand and develops tailored solutions for specific requirements.