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
Supplementary Services
Introduction
Tailor-made support designed with your project in mind
We offer a range of supplementary services to ensure that we can offer the highest quality support to our clients. Our consultants are on hand to offer guidance and advice every step of the way — giving your product the best chance of success in achieving and maintaining compliance.
And, if you don’t see what you need here or across our website, it doesn’t mean that we can’t assist you. The scope of our work is so varied and nuanced — and very niche in the majority of cases — that we can’t list it all here.
Get in touch with us today to discover how we can develop a bespoke offering to match whatever your requirement is.
Project
management
Our consultants have extensive scientific, healthcare, and pharmaceutical sector expertise and can provide leadership to a project team. Supporting projects from start to finish, our team is highly skilled and practically experienced with in-depth understanding of all aspects of the entire drug and device development process.
To find out more about our project management services, visit our resource centre
Agency meetings
Regulatory agency meetings play an integral role in responding to agency concerns and ensuring a smooth process from development to registration. Involving discussions and negotiations to ensure regulations are interpreted and applied correctly. Our team of consultants are highly experienced in taking agency meetings — such as IND, scientific advice, orphan designation, and pre-submission meetings — helping you to work through the complex arena of working with regulatory agencies.
To find out more details about specific ways in which we can help with agency meetings, visit our resource centre.
Import services
Manufacturing and Importation Authorisation (MIA) must be in place in order to import licensed medicines into the EU and the UK. Additionally a Qualified Person (QP) and Responsible Person (RP) must also be appointed to approve the overseas manufacturing site and be responsible for batch testing and release. Once a product is within the EU, a Wholesale Distribution Authorisation (WDA) is needed before distribution, along with other legal requirements.
Woodley BioReg works with non-EU manufacturers to enable them to import into Europe while incurring minimum cost. We have registered addresses in both the UK and Italy, meaning that we can offer import services to both the UK and the EU. We hold an MIA and WDL and have been audited by the UK’s MHRA and granted cGMP accreditation for our importation, warehousing, and distribution services.
For more information on import services and requirements, visit our resource centre.
