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  
               

2. REGULATORY DOCUMENTATION

Kinesis can assist in writing and preparing non-clinical and clinical documents that have to be included in a dossier for submission to regulatory authorities. Kinesis has experience with preparing documentation for a final submission according to the Common Technical Document (CTD) Module 2 format, like non-clinical and clinical overviews (former expert reports), and non-clinical and clinical summaries. This can either be in the context of a new drug application (for Europe both centralized or MRP-procedure), a bibliographical application or a generic application.

For documentation needed during drug-development Kinesis can assist in preparing (parts of) these documents (e.g. investigator’s brochure (IB), a summary for an investigational new drug (IND), and safety assessment document (SAD). Medical writing can be offered as well for documents that may have to be submitted after first approval of the drug, e.g. updates, registration renewal, or line extensions. Preparing documentation will of course take place according to the most recent FDA, CPMP and ICH guidelines and Notice to Applicants (NtA). See also our site about drugdevelopment.

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