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Regulatory Compliance

Comprehensive Pharmaceutical Regulatory Services

Your Partner in Achieving Market Compliance

Discover a suite of pharmaceutical regulatory services meticulously designed to navigate the complex African market landscape.

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From Registration Strategies to Marketing & Sales, our modular services are meticulously crafted to align with your market entry and growth aspirations.

Tailored for Your Success

Our Service Spectrum

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​Regulatory Intelligence

Regulatory Consulting and Quality Assurance

MC Pharma (Pty) Ltd is licensed under Section 22C(1)(b) of Act 101 (the Medicines and Related Substances Act 101, of 1965), and conducts various services to assist entities in operating the medical industry. Regulatory affairs consultancy and registration services include, but not limited to:

Medical form filled out by regulatory pharmaceutical consultant
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Section 21

​Authorisation Granted by SAHRPA

MC Pharma can assist with import and supply of unregistered orthodox medicine or veterinary medicine into Africa on a Section 21 basis.

regulatory pharmaceutical documents approved by African authorities
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Import & Export Services

Distribution & Wholesale

MC Pharma has agreements with major distributors and wholesalers:

  • Import and Export logistics.

  • Management of local warehousing and distribution.

  • Key Accounts Liaison.

Warehouse where registered medicines are being distributed
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New Business Development

​Business Development Services

  • Proactively seeking new business opportunities.

  • Research new opportunities and manage the company entry and development strategy.

  • Building business relations with current and potential clients.

  • Doing extensive research on all potential markets, products and potential clients.

  • Liaison with client and regulatory bodies for registration of products.

  • Maintaining short- and long-term business development plan.

pharmaceutical consultant discussing the new business development strategy
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Sales and Marketing

Sales & Marketing Team

  • Sales reporting and analysis.

  • Development of Marketing aids to suit Reps needs.

  • Documentation and detailing of products, new product launches in market.

  • Advertising Compliance and Certification.

  • Dedicated and experienced sales reps.

  • Marketing and design.

  • Market analysis.

pharmaceutical marketing and sales reports and data

Our Products Suite

Compliant, Reliable, and Market-Ready

Explore our range of products, each engineered to meet the rigorous regulatory standards of the pharmaceutical landscape in South Africa.

Our Products

Medical Products

Explore our range

Medical products already approved for South African market.

Our Products
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Adverse Drug Reactions

Prioritizing Patient Safety and Regulatory Compliance

Adverse Drug Reactions (ADRs) are a critical concern in the pharmaceutical industry. MC Pharma places paramount importance on understanding, managing, and reporting ADRs to ensure patient safety and adhere to regulatory standards for products registered on our license.

pharmaceutical consultant discussing with a client

Strategic Partnering

With the Future in Mind

Our aim is to become your strategic partner by understanding your strategic objectives, identifying the critical aspects of your business plans and matching the appropriate solutions to those plans

client and consultant agreeing on African medicinal market penetration strategy
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