Regulatory Authority Scientific Advice and its impact on your Development Strategy is critical. Kinesys’ experience and expertise in this area is essentially based on high quality people, sound strategy and informed guidance.
When do you request Scientific Advice on your development programme, what questions do you ask, and to whom? And how does this process fit with your overall Development Strategy?
Obtaining relevant Regulatory Agency buy-in to your development programme is critical to success but can cause a significant setback if managed badly.
Kinesys believes in combining the key components people, strategy and guidance to ensure a successful outcome.
High Quality People – with real experience managing Scientific Advice procedures and Development Programmes
Sound Strategy – formulated by good people utilizing their practical experience
Informed Guidance – ongoing development decisions based on sound strategy
Specific therapeutic area experience:
In recent years we have developed novel and important products for respiratory diseases, CNS conditions, oncology and haematology indications, epilepsy, diabetes and other metabolic diseases, rheumatology, systemic infection, hormone replacement, and patients requiring blood replacement factors, among others. In many cases this has required us to embark on a Scientific Advice process for our clients.
What differentiates us?
With an average of over 20 years pharma experience, Kinesys’ Principals, Senior Consultants and Advisory Board have a successful history in development and registration of NCEs and biotech products. Our combined expertise and practical approach provide a highly differentiated, high quality service. We have excellent relationships with key regulators at EMA, FDA and EU national authorities.