Regulatory Affairs Overview
We provide pharmaceutical product and devices development solutions to support emerging biotechnology companies, scientific innovators, medical devices companies and small pharmaceutical companies worldwide.
We help you to realise shareholder value by providing high quality, value-added services with a focus on successfully delivering shortened development pathways in carefully targeted indications.
Key to our success is our ability to quickly understand which pathway(s) work best for your product based on an excellent understanding of national, regional and international pharmaceutical law and guidelines, coupled with an ability to advance compelling scientific and clinical arguments.
Our team of regulatory experts are leaders in the field with experience across a wide range of specialities. The department is led by a trained lawyer and pharmacist with expertise in pharmaceutical law, and is supported by experienced scientists, physicians/clinicians, epidemiologists and health economic experts.
We offer services globally through our offices in UK, USA, Ireland, Canada and Australia. Our set up allows us to provide full service drug development solutions on a truly global scale.
Summary of services:
- Global CTAs (ie. EU CTAs, INDs, Australian CTNs etc)
- Marketing Applications (MAAs, NDAs, ,BLAs)
- Orphan Drug Development
- Paediatric planning including waivers
- Regulatory strategic advice including accessing Agency development support (eg Scientific meetings with regulatory Agencies) and early access schemes for products addressing an unmet medical need (e.g. EU PRIME, Innovation Task Force, Adaptive Pathways etc)
- Health economic value propositions
- Regulatory maintenance including label extensions and lifecycle support
- Pre-approval access programs including compassionate use programs, Named Patient Programs and Early Access to Medicines Schemes
- Medical devices development
- Micro, Small, medium-sized Enterprise (SME) qualification
- GxP inspection support
- Other service: Novel food, and Cosmetic development