iMVELO Consulting was founded by a Pharmacist with vast experience in production, quality assurance/compliance, pharmacovigilance and regulatory affairs and thus able to offer these consulting services.
SERVICES
- Licensing of Facilities and Good Manufacturing & Distribution Practices
- Quality Assurance/Compliance
- Regulatory Affairs
- Pharmacovigilance
- Medical Awareness and Training
- Medical Sales, Marketing and Promotions
- Sales promotion and marketing
- Medical product training
Details for the key services offered:
Licensing of Facilities and Good Manufacturing & Distribution/Warehouse Practices
- Drawing up and review of quality management systems, e.g. Standard Operating Procedures, Quality Manual, and Site Master File
- Application and maintenance of License
- Conducting inspections such as self – inspections, qualification of new suppliers and inspection of third parties.
Quality Assurance/Compliance
- Quality Management Systems
- Product Release
- Annual Product Reviews
- Master Documents
- GMP & GDP Training
- Vendor Audits
- Compliance – advertising and marketing code
- Packaging and marketing material review
- Assist in New Product Launch
Regulatory Affairs
- Conducting due diligence of dossiers for compliance with Health Authority Guidelines.
- Review and compilation of dossiers for both NCE and Generic Products including Biological & complimentary medicines products for registration in SA, Botswana, Namibia, Swaziland and Zimbabwe.
- Updates and maintenance of registered dossiers
- Amendment compilation and submission to health authorities
- Response to Health Authority committee recommendations
- Dossier conversion to CTD
Pharmacovigilance
- PV systems implementation and maintenance
- Training on PV procedures and guidelines
- PV Audits