We know how to overcome hurdles for routine or complex and unusual therapies in all key regions and in unfamiliar countries. Our Regulatory Team is responsible for numerous successful submissions to major competent authorities and regulatory agencies. Our skilled teams develop high-quality written documents that are compliant with global and national regulatory requirements.
We provide pharmaceutical product and device development solutions to support emerging biotechnology and medical device companies, scientific innovators and small pharmaceutical companies worldwide.
We help you to realise your product asset value by providing a customised, high-quality, value-added services with a focus on successfully delivering shortened development pathways in carefully targeted indications.
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. 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 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.
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 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, for example, the French ATU, and have worked with the UK regulatory agency to bring medicines to patients in greatest need under the UK EAMS.
Services we provide:
- Regulatory strategic advice including accessing agency development support (e.g. Scientific meetings with regulatory agencies) and early access schemes for products addressing an unmet medical need (e.g. EU PRIME, FDA BTD, Innovation Task Force, Adaptive Pathways etc)
- Health economic value propositions, global value dossiers, payer interviews
- Joint EMA/HTA parallel consultations
- Global CTAs (i.e. EU CTAs, INDs, Australian CTNs etc)
- Marketing Applications (MAAs, NDAs, BLAs)
- Orphan drug development
- Paediatric planning, including waivers
- 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, CE registration and maintenance
- Micro, Small, medium-sized Enterprise (SME) qualification
- GxP inspection support
- Other service: novel food, and cosmetic development
- From kick-off meeting to SIV in five days – a severe COVID-19 pneumonia case-study Explore
- Effective Pharmacovigilance & Regulatory EU and Australian Due Diligence, leading to operational and consultative support Explore
- Bionical Emas Regulatory Affairs: Mutual Recognition Submission Strategy Explore
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