Ongoing Licence Maintenance throughout a product’s lifetime

Following approval, Marketing Authorisation Holders (MAHs) must ensure licence maintenance measures are in place to ensure that approved licences are maintained — ensuring patient safety at all times.

At Woodley BioReg, our team of specialist quality and regulatory consultants offer a full range of services to support MAHs in maintaining their Product Licence(s). In particular, following the review of over 10,000 Mas (including Biologics Licences), Woodley BioReg is able to provide an insight into the key risk factors for licence maintenance and avoid things like 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.

Our experience of over 10,000 MAs approved globally, including both biological and pharmaceutical products, shows that 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.


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 will help 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.

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Whether it’s a variation due to an amendment in legislation or regulatory requirement, or a change implemented at the manufacturing stage, we will help you prepare, group and submit licence variations so that you can concentrate on the more exciting regulatory challenges.


Having achieved GMP certification and product approval, we will help you in ensuring that all aspects of quality compliance are managed and maintained. This includes guiding and delivering change controls, deviations, investigations, and audits.

Pharmacovigilance (PV)

All Marketing Authorisation Holders 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 support you in developing a fit-for-purpose system, and maintaining it, in-line with changes to MAs, including variations, renewals, and change of suppliers — supporting your PV activities.

To find out more about pharmacovigilance, visit our resource centre.

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Compliance and conformance

From the ongoing management of your QMS and GMP accreditation, together with 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 have we help our clients with these activities, visit our resource centre.

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Even after receiving your Biologics Licence Authorisation 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.

The work has only just begun after obtaining an MA — maintaining your licence can be challenging and time consuming, and often not seen to be rewarding. At Woodley BioReg, we’re here to help with practical and strategic advice and guidance based on our depth of knowledge, expertise and experience. With our global presence and reach, we can ensure your products are available to patients all over the world.

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