KeVaRo Group
Consultancy and service provider focused on quality assurance and good pharmaceutical practices. Maintains Manufacturing & Import Authorization and GMP certificates from the Bulgarian competent authority, provides Qualified Person (QP) services including batch certification and release, chemical/physical quality control testing, GxP auditing and inspection support, QMS establishment and remediation, and training. Operates a licensed QC laboratory and performs importation and batch certification activities under EU regulatory frameworks.
Industries
Nr. of Employees
small (1-50)
KeVaRo Group
Sofia, Grad Sofiya, Bulgaria, Europe
Services
EU QP services for batch certification and release of commercial and investigational medicinal products, IMP certification support, and site of physical importation services.
Chemical and physical analyses of bulk and finished medicinal products performed to European Pharmacopoeia standards and manufacturer registration files.
Independent supplier, manufacturing site and clinical site audits; pre-inspection GAP assessments; inspection support and CAPA planning.
Implementation and remediation of quality management systems, SOP development, root cause analysis and remediation tracking.
Interactive GxP training programs tailored to organizational needs, including auditor behavior training.
Support services including vendor qualification, complaints handling, mock recall exercises, warehouse temperature mapping, medical writing and patient support program implementation.
EU QP services for batch certification and release of commercial and investigational medicinal products, IMP certification support, and site of physical importation services.
Chemical and physical analyses of bulk and finished medicinal products performed to European Pharmacopoeia standards and manufacturer registration files.
Independent supplier, manufacturing site and clinical site audits; pre-inspection GAP assessments; inspection support and CAPA planning.
Implementation and remediation of quality management systems, SOP development, root cause analysis and remediation tracking.
Interactive GxP training programs tailored to organizational needs, including auditor behavior training.
Support services including vendor qualification, complaints handling, mock recall exercises, warehouse temperature mapping, medical writing and patient support program implementation.
Expertise Areas
- Regulatory compliance and Qualified Person services
- GMP compliance and manufacturing oversight
- Quality control testing (chemical/physical)
- GxP auditing and inspection readiness
Key Technologies
- High-performance liquid chromatography (HPLC)
- Physicochemical assays per European Pharmacopoeia
- Environmental monitoring and temperature mapping
- Batch release and certification processes
News & Updates
Public tender / procurement documentation posted (project procurement details and scope).
Manufacturer/Importer Authorisation (BG/MIA-0503) covering manufacturing operations, importation, and batch certification activities for human medicinal products.
GMP compliance certificate issued following national inspection; inspection noted on 2025-02-04 confirming compliance with EU GMP principles for specified activities.
GMP compliance certificate for quality control testing (chemical/physical) at the licensed QC laboratory site.
Public tender / procurement documentation posted (project procurement details and scope).
Manufacturer/Importer Authorisation (BG/MIA-0503) covering manufacturing operations, importation, and batch certification activities for human medicinal products.
GMP compliance certificate issued following national inspection; inspection noted on 2025-02-04 confirming compliance with EU GMP principles for specified activities.
GMP compliance certificate for quality control testing (chemical/physical) at the licensed QC laboratory site.