Coldwell Pharma
regulatory affairs quality assurance readability test pharmacovigilance development

gomb Regulatory Affairs

Consultancy & project management in

  • Planning of the regulatory strategy for the customer
  • Registration of new pharmaceutical products
    • National procedure
    • MRP procedure
    • DCP procedure
  • Renewal of a Marketing Authorisation
  • Variation of a Marketing Authorisation
  • Transfer of a Marketing Authorisation
  • Draft of an API declaration (Annex 5.22 to Appl.Form)
  • Applications for final sample approval in Hungary
  • Applications for Batch specific variation of Out of Specification status of the packaging material or laboratory findings
  • Application for EAN code registration
  • Correction & Proof Reading of the Artworks of Packaging Materials


Contact in Regulatory 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

 

 

 

 

 

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Coldwell Pharma