Preclinical / Nonclinical
Preclinical (nonclinical) development refers to the process through which investigational drugs are subjected to extensive laboratory testing to determine their safety for humans.
Pharmaceutical
Maintenance
Introduction
Ongoing Licence Maintenance throughout a product’s lifetime
Following approval, Marketing Authorisation Holders (MAHs) must implement licence maintenance measures to ensure that approved licences are maintained — protecting patient safety at all times.
At Woodley BioReg, our team of specialist quality and regulatory consultants offer a range of services to support MAHs in maintaining their Product Licence(s). In particular, following the review of over 10,000 MAs, Woodley BioReg is able to provide an insight into the key risk factors for licence maintenance, and helping to avoid registration drift and potential regulatory agency action.
Gap analysis
Following the approval of a product licence application, manufacturers are authorised to sell their medicine for the approved indication. Whilst this is often seen as completing a major milestone in the product’s development, it also marks the start of licence maintenance activities. In our experience, many manufacturers fail to discharge their responsibilities adequately leading registration drift. Our industry-leading and risk-based bespoke remediation processes can quickly bring manufacturers back into conformance and compliance, eliminating the risk of product suspension and regulatory agency action.
Registration
drift
Coined by Woodley BioReg’s own expert regulatory professionals, the term “registration drift” refers to the process where a product licence or Marketing Authorisation drifts away from the details approved for the methods, processes, and controls used for the manufacture of an approved product. If left unchecked, it can seriously impact on patient safety, and result in regulatory action and significant financial penalties.
We can support you to diagnose and remediate registration drift, ensure the maintenance of your licences and the ongoing safety for patients.
For more information about registration drift and how we can help you avoid it, visit our resource centre.
Licence
variations
Whether it’s a variation due to an amendment in legislation or regulatory requirement, or a change implemented at the manufacturing stage, we can assist you to prepare, group and submit licence variations so that you can concentrate on the more exciting regulatory challenges.
Ongoing
quality
Having achieved GMP certification and product approval, we will help you in maintaining and managing all aspects of quality compliance. This includes guiding and delivering change controls, deviations, investigations, and audits.
Pharmacovigilance (PV)
All Marketing Authorisation Holders (MAHs) for any medicinal product authorised or registered within the EU and UK must submit information relating to the pharmacovigilance of their medicines, regardless of where the MAH is located — ensuring patient safety throughout the European region. Our fully trained and EMA-registered specialist team (including our QPPVs) will help you develop a fit-for-purpose system, and maintain it in-line with changes to MAs — including variations, renewals, and change of suppliers.
To find out more about pharmacovigilance, visit our resource centre.
Compliance and conformance
From the ongoing management of your QMS and GMP accreditation, including change control, to ensuring your products continue to conform to your licence, we will assist you in maintaining the correct environment for the manufacture of pharmaceutical products.
To find out more about how what we mean by compliance and conformance, and how we help our clients with these activities, visit our resource centre.
Regulatory
strategy
Even after receiving your Marketing Authorisation (MA) approval, it is vital that you continue to develop, shape, and review your regulatory strategy as legislation and manufacturing methods are constantly advancing. Our regulatory team will ensure that you not only stay on track, but also guide you to ensure you capitalise and grow your markets and clinical indications globally.
