Coldwell Pharma
regulatory affairs quality assurance readability test pharmacovigilance development

gomb Strategic planning

Consultancy & project management in

  • Strategic planning for
    • Regulatory Submissions of Medicinal Product
    • Qualification and/or Notification of Medical Devices
    • Qualification and/or Notification of Food Supplement & Cosmetics
    • Product Launches in relation of patent expiry
    • Outsourcing of packaging/re-packaging processes
    • Outsourcing of warehousing, batch control and batch release processes
    • Portfolio Management
  • In-Licencing procedures
    • Dossier Checking before in-licencing
    • Writing / Review of Licence and Supply Agreements
    • Writing / Review of technical Agreements
  • Training for non-European Pharmaceutical Industry players about European regulation in
    • Registration of Medicinal Products in the European countries
    • Qualification and/or Notification procedure of Medical Devices in the European countries
    • Qualification and/or Notification procedure of Food Supplement & Cosmetics in the European countries
    • Batch testing and batch release of products for the European markets

 

Contact in Strategic/Business Development issues:

Dr Kósa Edit
Qualified Person in Quality Assurance:

Phone: +36 30 625 9842
E-mail: info@coldwell.hu or edit.kosa@gmail.com

gomb
Contact

Coldwell Pharma Bt.

established
in 2001 July

mail
1028 Budapest, Gazda utca 41. Hungary

parag
Dr. Edit Kósa

managing director

at
Contact:

info@coldwell.hu

+3630 625 9842

 

 

 

 

 

code, design:
adamkobor

 
Coldwell Pharma