About us

At ProReg Solutions we offer a comprehensive range of Specialist Regulatory Affairs Pharmacist services backed by many years of diverse experience to help navigate the complex regulatory landscape of the Pharmaceutical Industry in South Africa and neighboring countries.


We combine a deep understanding of regulatory requirements with a strategic approach to problem-solving. By applying critical thinking to every regulatory challenge, we proactively identify potential risks and opportunities, providing solutions that are not only compliant but also forward-thinking. At ProReg Solutions, we are dedicated to providing expert regulatory affairs consulting services to the Pharmaceutical, Biotechnology, and Healthcare Industries, working closely with your team to develop effective regulatory solutions and strategies, streamline submission processes, and ensure that your products remain compliant throughout their lifecycle.


We stay at the forefront of regulatory affairs by continuously monitoring and adhering to the latest local regulations and guidelines. Our team ensures full compliance with evolving industry standards, guaranteeing that your product is always aligned with the current legal landscape.


At ProReg Solutions, we are committed to helping you achieve your goals with precision, efficiency, and confidence.

Services

Dossier Compilation

Compilation of new product dossiers: Allopathics, CAMS & Biologicals

Post-registration Variations

Compilation of CMC, Clinical & Inspectorate Post-registration variations, including Baseline dossiers for Allopathics & Biologicals

Dossier Review

Dossier Due Diligence for suitability of registration 

Translations

Translation of PI's, PIL's & Labels into Afrikaans

eCTD v. 3.1

New Product Registration Dossiers and Post-registration Variations presented in eCTD v. 3.1 format

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