Bene-Taglio offers a comprehensive suite of regulatory services tailored to the healthcare and pharmaceutical sectors. Our goal is to ensure full compliance while positioning your business for operational excellence and growth.
Whether launching or restructuring—our solutions are crafted to help you succeed.
SAHPRA Compliance Services
Medical Device Distribution Licences (Import/Export)
• Drafting and submission of new applications and amendments
• Creation of supporting documentation including Quality Manuals
• Submission and query management, including response to SAHPRA inputs
Application Review & Advisory Reports
• Comprehensive evaluation of existing applications with actionable recommendations
Pharmacovigilance Systems
• Development and maintenance of Pharmacovigilance Master Files
• Adverse event reporting systems and risk management implementation
Regulatory Compliance Strategy
• Custom strategy development and execution for ongoing regulatory adherence
– Complementary Medicine Registration
– Cannabis Cultivation Licensing
SAPC Compliance Services
Community Pharmacy Licensing
• End-to-end support from application drafting to submission
• SOPs, Site Master Files, and operational documentation preparation
• Inspection readiness (GPP/GMP)
• Pharmacy operational systems, supplier management plans, and marketing strategies
Hospital and Wholesale Pharmacy Licensing
• Application development, submission support, and compliance review
SAHPRA related Services
- Medical device distribution licence [new and amendments]
- Medical device manufacturing licence [new and amendments]
- Complimentary medicine listing [new and amendments]
- Pharmacovigilance
- Regulatory compliance
What Do Our Clients Say?
As a medical specialist, I was not sure how to approach SAHPRA regarding my intentions to apply for a medical device distribution licence, but these guys made the process seamless and today I am an authorised medical device distributor.
We are already operating in the medical device industry but needed a medical device manufacturing licence and within a few weeks, we got it. we highly recommend them.
