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 in-house nonclinical, clinical, regulatory, quality, and CMC 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 early preclinical development right through to product licensure, 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 candidate molecules in volunteers and patients and form a key part of the clinical development strategy. For biopharmaceuticals, it’s not easily possible to use other techniques and methods in place of clinical trials to compare existing treatments, or to assess treatments in a new or different population group.
The processes and equipment used to manufacture biological products can be particularly complicated — even more than for pharmaceutical products. We help our clients design manufacturing processes that ensure product yield, purity and bioactivity, and process scalability, while ensuring compliance to all elements of regulatory and quality requirements.
Moving from the clinical development stage to preparing for Biologic Licence Authorisation (BLA) / Marketing Authorisation (MA) can seem daunting, but with structured and tailored support from our regulatory consultants at Woodley BioReg, the process can be painless.