OUR SERVICES

What we offer

Registration & Commercialisation of Allopathic Medicine

Registration of Commercialisation of Complementary Medicine

Registration of Commercialisation of Medical Devices and IVDs  

1. SAHPRA Applicant Platform

Applicant / Marketing Authorisation Holder Service enabling Marketing & Distribution Partnerships and Product In-Licensing Agreements:

SAHPRA Manufacturer, Importer and Exporter License

SAPC Manufacturing Pharmacy License DoH Premises License

PICs aligned Quality Management System

GMP compliant

ISO-13485 compliant

SAPC registered and recorded Responsible Pharmacist

2. Regulatory Support & Compliance

ICH-Aligned eCDT Dossier complilation, submission, registration

Allopathic (Category A) Human Medicines

Allopathic (Category C) Veterinary Medicines

Complemetary (Category D) Medicines
   - Human
   - Veterinary

Product Life Cycle Management, Registration & Listing of Medical Devices and IVDs

Medical Devices

In vitro diagnostics

Product Regulatory Support & Compliance

Adverse Event Reporting:

Robust pharmacovigilance systems to ensure patient safety

Labeling and Packaging

Comply with regulatory requirements for product labeling, packaging, and patient information.

3. Product Quality Management

Product Quality Management

Analytical testing

Batch Release

Product release

Deviations

Out-of–trends

Product reviews and trending

QMS maintenance

Product Out-of-specifications

Product complaint management

Product recalls

Change control

APQR

Pharmacovigilance

Facility Audits

4. Product Commercialisation

Product Business Case Development

Understand the Market through Market Research

Competitor Analysis

Stakeholder Analysis (healthcare providers, patients, payers, and distributors).

Patient Flow mapping

Sales Projections

Effective Marketing and Communication Strategy

Branding: Develop a strong brand identity and messaging

Multi-Channel Marketing

Key Opinion Leader (KOL) Profiling and Engagement

Patient Education

Medical Affairs Support

Phase IV Research

Marketing Material Approval

Sales Force Readiness

Sales Force employment

Training: Training on product, competitive landscape, and customer needs.

Territory Planning: Optimize sales territories to maximize reach and efficiency

Product Launch Management

Monitor launch performance throuogh sales, market share, and customer feedback.

Strategy adjustment based on real-time data insights

Monitor

Pricing and Reimbursement Strategy

Market-Based Pricing

Reimbursement Negotiations

Stakeholder / Account Management

Supply Chain Management

Stakeholder Management

Build and maintain relationships with prescribers

Patient awareness campaigns and support programs.

Payers and Policymakers

Risk Management

Legal and Ethical Considerations Intellectual Property Protection: Secure patents and trademarks to protect the product

Compliance: Ensure all promotional activities adhere to legal and ethical standards

Transparency: Maintain transparency in clinical data and marketing communications

Continuous Improvement

Adapt strategies based on market response and emerging trends

COMING SOON -

All products will soon be available in our online store - https://apotek.co.za