Regulatory Services
Akos offers the full range of Regulatory Services to support your product at all stages of development, from concept to launch and beyond. Each client is allocated to a Regulatory specialist, who will be the primary contact, and a back-up specialist. Many of our specialists have more than 20 years' experience in the Pharma Industry. Having discussed with you the product, your aims and your regulatory needs, they will be able to provide detailed plans to achieve your agreed objectives. Whether it is a full eCTD or a rewrite of your package insert, a complete regulatory development strategy or a first-time in man CTA, Akos can provide the expertise you need.
Akos offers you the full benefit of our highly experienced Regulatory Affairs team in the following areas:
- Marketing Authorisation Applications (MAA), New Drug Applications (NDA)
- Electronic Common Technical Documents (eCTD) prepared using leading edge technology
- Regulatory Development Consultancy
- Risk Management Plans (RMP)
- Clinical Trial Authorisations (CTA), Investigational New Drug Applications (IND) and Investigational Medicinal Product Dossiers (IMPD)
To discuss your regulatory questions with Akos please contact us:
Tel: +44 (0)1582 766 339
Email: regulatory@akos.co.uk