Welcome to PHARMERS

Here are 55 ways in which we can help you: 

A Responsible Pharmacist Application Locums:

· 3 or 6 months IRP locum (pre-license)

· Recording / monthly locum (post-license)

B Medicine Registrations + Lifecycle Management:

· eCTD Baseline registrations (MRF/MBR - Seq 0000) 

· eCTD NCEs, Biologics medicine registrations

· eCTD Generic medicine registrations

· 3D-listing complementary medicines registration

· Complementary medicine label reviews 

· Vet medicine registration (DAFF Act 101 & Act 36)

· Pharmacovigilance updates + reports (ADRs, ICSRs, AEFIs)

· Medical writing compilations (m1.3 PI/PIL/Label/translations)

· Section 21 applications 

· Clinical trial protocols 

· NAPPI CODE applications 

· Detained CatD release 

C Pharmaceutical Licenses:

· GPP Premise scouting (within SA)

· Health shop establishment 

· New pharmacy feasibility study (mini / full) 

· Community pharmacy x 5 packages (SAPC + NDoH)

· Compounding only restriction (SAPC + NDoH)

· Wholesale pharmacy (SAPC + NDoH + SAHPRA)

· Manufacturing pharmacy (SAPC + NDoH + SAHPRA)

· Import / Export manufacturer only 

· Cannabis licenses (cultivate, manufacture, export)

· Business cash flow forecast (loan application)

· Pharmacy rescue / revamp / innovation audit

· Recording / Medical aid accounts / SOPs / Policies

· Licensed establishment sale and purchasing 

· SAPC pharmacy grading Inspection pack 

D Medical Device Establishment Licenses:

· Distribution license only (SAHPRA)

· Wholesale license only (SAHPRA)

· Manufacturing license only (SAHPRA)

· Any Medical Device license + ISO 13485 (SAHPRA)

· ISO 13485 certification only (SAHPRA)

· Radiation device 

E Professional Council Registrations:

· Pharmacists (annual renewal / foreign)

· Nurses+ (annual renewal / foreign)

· General practitioners (annual renewal / foreign)

· Intern exam prep 

· Pharmacist CPDs (8 pack)

F Business Development:

· NHI Readiness Strategy 

· Pre-license and post-license compliance strategy 

· Pharmaceutical organizational strategy (plan)

· Regulatory intelligence (plan / retainer)

· Regulatory marketing, marketing material and artwork design / review 

G Quality System Documents: 

· Compilation of quality policy, 

· Compilation of quality manual

· Compilation of Site Master File (SMF)

· Compilation of Standard Operating Procedures (SOPs)

· Facility audit (GMP, GPP, GWP, GCP, GRP)

· Stability protocols

· Validation protocols

H Recruitments + Retainers + Reps: 

· Short placement (organizations/ professionals)

· Permanent placement (organizations/ professionals)

· 6 or 12 months consultant retainers

Sale representatives programme 

You now have an entire regulatory department with us!