emas regulatory affairs

Regulatory Affairs

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
emas regulatory affairs

Orphan Drug Development

Orphan drugs are covered by a specific individual legal system endowing them with a special status. Granting orphan drug status is based upon an application dossier, which if successfully approved results in a number of incentives in terms of R&D, intellectual property and marketing. At Bionical Emas, we are experts in orphan drug development having worked on more than 15 submissions in the last year alone. We are able to identify the most appropriate orphan indication and extract the most potent arguments from the available data leading to successful outcomes in nearly all cases.

Paediatric Planning

Paediatric development is critical to all product development plans with both US and EU Agencies focused on encouraging paediatric studies in parallel to the development of the product in adults.  At Bionical Emas, we have experience developing paediatric plans in a wide range of indications and conditions. We support protocol development drawing on our network of KOLs and work with both FDA and EMA to design paediatric development programs which are both compliant and feasible. Our strategy for waivers and deferrals is designed to keep paediatric studies off the critical submission path for first product approval in both Europe and the US.

Financial Incentives

Our team of experts has a good understanding of the various grants, schemes and financial incentives open to sponsors wishing to develop their medicines. We have particular expertise in SME qualifications and have successfully applied for SME status for a number of VC- and self-funded ex-EU companies.

Early Access Schemes for Products Addressing an unmet medical need

Early Access to Medicines Schemes aim to provide patients with life threatening or seriously debilitating conditions access to medicines that do not yet have a marketing authorisation when there is a clear unmet medical need. At Bionical Emas, we have a wealth of experience working both independently and with third party providers to deliver early access Named Patient Programs. We have been involved in compassionate use programs, in particular the French ATU, and have worked with the UK regulatory agency to bring medicines to patients in greatest need under the UK EAMS.

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