Stop at PHARMERS for all your healthcare consulting needs

Here are 22 Ways in which we can help you: 

• Appeals to declined/rejected outcomes
• Company compliance, licenses setup and due diligence 
• Regulatory intelligence and organizational strategy
• marketing, artwork and label reviews
• QMS company set up and compilation (Quality Manuals, Site Master Files, SOPs etc.)
• Medical Devices establishment QMS including ISO 13485
• Manufacturer, Wholesaler, Distributor, Importer /Exporter licenses
• Module 1.3 compilation and translations 
• Due diligence on dossier information
• eCTD Variation applications (MRF/MBR to Baseline 0000)
• eCTD Medicines Registrations– New Chemical Entities, Biologicals, Vaccines
• eCTD Medicines Registrations – Generics based on Bioequivalent studies, clinical data, biowaivers in terms of BCS classifications
• Complementary Medicines (CAM review + 3D listing)
• Act 101 & Act 36 Vet Medicine applications (DAFF)
• PI & PIL Safety and pharmacovigilance (PV) updates 
• Auditing of all facilities  (Current GMP, GLP, GWP and GCP)
• Stability and validation protocols
• SAHPRA applications including Section 21
• HPCSA applications
• SAPC applications
• SANC applications
• NDoH applications
• Pharmacy sales & purchases

Whether listed or not; we've got a service or package that will fit you! Explore once-off or retainer options for your regulatory needs. 

You now have an entire regulatory department with us!