Contract Research Organisation
Akos was founded in 1986 and has become a leading provider of Drug Safety / Pharmacovigilance and Regulatory Services. We support Pharmaceutical and Biotechnology companies in Europe, US, Canada and Asia to achieve success in Development, Marketing Authorisation and Post-Marketing support activities.
Akos offers experience and expertise to provide rapid, effective solutions to meet client needs, ensuring compliance with ICH, FDA and EMEA standards. Akos Drug Safety / Pharmacovigilance and Regulatory Services are founded on the philosophy and focus that each step in the drug development process must, in a timely and cost effective way, add value to and serve the ultimate imperative of marketing authorisation approval.
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.
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Drug Safety / Pharmacovigilance
Akos offers established full Drug Safety / Pharmacovigilance services. Each client is provided with a bespoke solution to meet their specific requirements, including both global and local projects from Phase 0 throughout the whole of the product life cycle..
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