Kinesis: CRO in Drug Development and pharmacokinetic

REGULATORY CRO SERVICES

 
Preclinical CRO services
Clinical CRO services
Regulatory CRO services
Population PK/PD modeling
Ghostwriting
Insourcing
 
  o preclinical consultancy.htm
o Study design and protocol writing
o Pharmacokinetic analysis and reporting
o Project management and study monitoring		 o Clinical consultation
o Study design and protocol writing
o Biometrics and report writing
o Project coordination		 o Regulatory affairs consultation
o Regulatory documentation
o Expert reports
o Actualisatie oude dossiers 		Population PK/PD modeling Ghostwriting Insourcing  
               

1. REGULATORY AFFAIRS CONSULTATION

Kinesis provides advice on regulatory procedures and issues. We can give guidance on to what kind of non-clinical and clinical studies and what kind of documentation are needed to receive a marketing authorization for your product from the regulatory agencies. Kees Groen and Patricia Baede of Kinesis previously worked for the Medicines Evaluation Board (CBG-MEB) in The Netherlands (hyperlink naar www.kinesis-pharma.com). During that time they also reviewed dossiers submitted to the EMEA/CPMP as part of the centralized procedure. People of Kinesis have attended meetings at the CDER department of the FDA (Food and Drug Administration) to present a product in a scientific advice or to defend a submission in a hearing. See also our site about pharmacokinetic support.

 

Address:

Lage Mosten 29
4822 NK Breda
The Netherlands
+31(0)76 54 80 666
+31(0)76 54 21 777 (Fax)

(c) 2003-2004 Kinesis, the Netherlands
info@kinesis-pharma.com