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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.

scientific_advice


The Challenge

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.

  • How does the Scientific Advice process work within different Authorities? How do you follow up on the advice?
  • How can you ensure that the major Regulatory Authorities understand your proposed development programme and give relevant advice?
  • When should you speak to national competent authorities in EU – before, after, or instead of going to EMA for formal Scientific Advice?
  • If you are conducting a global development programme, do you approach FDA and EMA simultaneously or in sequence?
  • How do you resolve conflicting advice from different EU authorities anddifferent requirements between USA and EU?
  • How do you avoid conducting studies for only one region and generate a genuine global registration package?
  • Which EU national competent authorities are most capable of advising on your particular product?

Kinesys believes in combining the key components people, strategy and guidance to ensure a successful outcome.

The Solution

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.