Kinesis: CRO in Drug Development and pharmacokinetic

REGULATORY CRO SERVICES

 
Preclinical CRO
Clinical CRO
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  
               

3. EXPERT REPORTS

In case of a generic application, a literature overview of non-clinical and clinical data is mostly required. Kinesis has previously assisted in writing expert reports to support for example, the registration for a generic product based on a bioequivalence study or to support a new indication for a cardiovascular product. On request Kinesis can perform a literature search to find data supporting the SPC or labeling text, especially on posology and indications. Kinesis can prepare a summary overview of selected literature references.

For starting a mutual recognition procedure (MRP), not only the SPC of the reference member state (RMS) will be taken into account, but also the originator’s SPCs of the Concerned member states (CMS) to facilitate harmonization.

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