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.
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.
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.
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.
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.
Formally reviewed and approved clinical trials are used to determine the safety and efficacy of a candidate drug in volunteers and patients and form a key part of the clinical development strategy. Where it’s not easily possible using other techniques and methods, clinical trials can be used to compare existing treatments, or to assess treatments in a new or different population group.
The processes and equipment used to manufacture medicines can be complicated — after all, patient safety is at risk when mistakes are made. We help our clients design manufacturing processes that ensure product yield and process scalability, whilst ensuring compliance to all elements of regulatory and quality requirements.