Our specialist team looks at the big picture and provide a tailored service to match your needs.
Whether you require a one off service or the complete package we offer flexible solutions to meet your needs. We offer a wealth of experience working with UK and international clients covering all phases of drug development from innovative and generic products to herbals and advanced therapies.
The role of the EEA Qualified Person for Pharmacovigilance (EEA QPPV) is critical for a company and the choice, experience and knowledge of the EEA QPPV should not be overlooked in the safety management of your products; they are responsible for ensuring your systems and processes are in compliance with the legislation. The services are supported by a full back-up system to comply with the 24/7 requirement and GoldenZone’s internal Quality Management System (QMS).
Based on global experience, our goal is to help our clients be compliant with the relevant PV legislation along with managing the risk-benefit profile of products. GoldenZone can support your PV requirements from your Marketing Authorisation Application (MAA) through the entire post-marketing life cycle. We have experience of national approval through decentralised procedures to centralised approval in the EU via the EMA.
Safety monitoring in clinical trials is integral to the conduct of clinical research to ensure both patient safety and integrity of study data. We have an extensive understanding of regulatory reporting requirements and continuous regulatory intelligence ensuring ongoing compliance.
Whoever you deal with will treat your request as a priority with a smile on their face.EMAIL US » +44 (0)33 33 44 55 45
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