Regulatory Development Consultancy
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With the costs and the risks of pharmaceutical development ever increasing, and even one month's delay in approval costing many thousands of pounds in lost revenue, a sound Regulatory Development Strategy is essential. A development strategy is multi-faceted and will be unique to your product and your commercial objectives. Akos can guide you through the necessary decision-making steps: the route of the submission, the legal basis of the application, the indications that can be supported by the available data or the additional data needed to support your preferred indication. We can provide expertise in paediatric investigation and risk management plans. We can co-ordinate meetings with competent authorities for scientific advice or protocol assistance as required, and implement measures to take advantage of the incentives offered for companies developing orphan medicinal products and those qualifying for small and medium sized enterprise (SME) status.
The Regulatory Strategy is an organic structure: it may be necessary to adapt the strategy in light of internal factors such as study results or external factors such as legislative changes. Where Akos is engaged for ongoing regulatory support we can anticipate and accommodate these changes and advise on any measures necessary to keep the Regulatory Strategy current and competitive.
Akos can help with all of the following, and more:
- Regulatory submission and approval strategy
- Review and advice of CMC, Preclinical and Clinical programmes in relation to regulatory requirements
- Organisation of scientific advice and protocol assistance consultation with competent authorities (EU, FDA, Health Canada)
- Orphan drug applications
- Small and Medium Sized Enterprise status
- Paediatric Development in EU (PIP & PUMA) and US (PREA)
To discuss your regulatory questions with Akos please contact us:
Tel: +44 (0)1582 766 339
Email: regulatory@akos.co.uk