Happy january
hi there,
Welcome to PHARMERS
We are a group of progressive, expert medico-pharmaceutical consultants. Here to provide peace of mind to applicants and lice
our values
Innovation
Introducing new ideas, methods, or solutions to the medico-pharmaceutical world is how we roll. Not just for fluff, but improvement and impact. When we go beyond traditional solutions its with our clients in mind. We don't copy anyone else in the market; we present something better.
Excellence
We consistently pursue and deliver the highest standards of quality, performance, and integrity in our projects for our clients. If you want a team of consultants to go beyond the minimum requirements to achieve outstanding results on your behalf, contact us.
Efficiency
We specialize in achieving your realistic desired outcome using the least amount of time, effort, or resources without sacrificing quality. Thats why we do things right instead of just doing the right things. You definitely get out, more than you've put in.
Reliability
Trustworthiness is integral to our operations. Hundreds of clients have put their trust in us and have consistently delivered on our promises and even exceeded expectations and outcomes. Trust that we've been doing it!
Expertise
You don't have to wonder if we know what we're doing or not. All our consultants have practical & relevant expertise in the projects they work in.
Healthcare professionals and members of the public:
Welcome
There's much to see here. So, take your time, look around, and learn all there is to know about us. We hope you enjoy our site and take a moment to drop us a line.
Look through our amazing pages to see what we can assist you with!
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Core Compliance & Regulatory Work
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!
Various License Packages
Theres something tailored for every desire!