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Regulatory Services in South Africa

Regulatory Compliance Experts in South Africa

The South African Health Products Regulatory Authority (SAHPRA) of the Department of Health, is the national regulatory authority of South Africa. It is responsible for all regulatory activities including registering, monitoring, evaluating, and inspecting medicinal products such as drugs, biologics, Expert medical devices Services, and in vitro diagnostics. SAHPRA partners with other committees and organizations to ensure harmonization in regulatory processes. These include the International Pharmaceutical Regulators Programme (IPRP) that was established to facilitate regulatory cooperation between members, and the African Medicine Regulatory Harmonization (AMRH) to enhance the harmonized regulation of medicinal products in Africa and provide safe and efficacious medicinal products to the public as efficiently as possible.

As a leading global contender, DDReg’s regulatory services in South Africa provides ongoing support and development of customized strategies during all regulatory phases while keeping track of the most recent regulatory requirements to ensure high quality and timely submissions. We deliver reliable safety measures, ensure risk mitigation, and collaborate with experts to facilitate effortless delivery of product launches, regulatory filings, and market authorizations.

Our Regulatory Consulting Services In South Africa Portfolio Covers

  • Regulatory Strategies and Expert Views
  • Regulatory Due Diligence
  • Gap Analysis and Remediation
  • New Product Authorizations
  • Post Approval Life Cycle Management
  • CMC Advisory
  • API/DMF
  • ICSR Processing and Submission
  • Risk Management
  • Aggregate Reports
  • Signal Management
  • QPPV Services
  • Bio Waiver Justifications
  • Clinical & Non-Clinical Experts Reports
  • IPR Support, including Worldwide Patent Status and Patent Reviews
Contact our experts today !
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Call us on:+1 (302) 601-2755
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