 Quality Assurance (QA)
Consultancy & project management in
Strategic Planning of the flow of information, flow of goods and flow of samples until the final batch release for sale, involved the elaboration of QA processes of
- Toll-Manufacturing
- Batch Release of Medicinal Products from Third Countries
- Packaging or Repackaging of Medicinal Product
- Wholesaling
We offer the following services in the above QA projects:
- Set up quality assurance system
- Preparing SOPs
- Preparing Site Master File
- Writing QA contracts (Technical Agreements)
- Investigating of non-compliant cases and compiling Reports, like
- Reject Notification
- Complaints Notification
- Deviation Notification
- Rapid Alert
- Auditing of suppliers' manufacturing sites
- Performing self-inspections
- Coaching to Authorities' inspection or sponsor's audit
Contact in Quality Assurance issues:
Dr Kósa Edit
Qualified Person in Quality Assurance:
Phone: +36 30 625 9842
E-mail: info@coldwell.hu or edit.kosa@gmail.com |
Contact
Coldwell Pharma Bt.
established
in 2001 July
1028 Budapest, Gazda utca 41.
Hungary
Dr. Edit Kósa
managing director
Contact:
info@coldwell.hu
+3630 625 9842
code, design:
adamkobor |
