About Us

SAMRAC is a South African based regulatory company, specialising in all fields of medicines registration and quality related aspects in Africa. We are a team of eight regulatory pharmacists and specialists with more than 100 years of combined experience. We provide a professional, yet personal and friendly service to our clients. We can provide you with a tailormade service for your company’s regulatory needs. We look forward to welcoming you to our family.

Our Services

Dossier due diligence.

Dossier compilation for applications for registration (NCE, Generics and Complementary Medicines)

Dossier compilation for application for registration in African countries


Medical device applications

Compilation of dossier variations/amendments

Compilation and review of Professional information (PI), Patient information leaflets (PIL) and Labels.

Professional information (PI) and patient information leaflets (PIL) safety and pharmacovigilance updates

MBR1 and MFR1 conversion to eSubmission and eCTD format.

Licence Applications (SAPC, DOH & SAHPRA) for manufacturers, applicant import/export, wholesalers and distributors.

Licence Applications for Medical Device companies and CAMS companies.

Application for clinical trial submissions to SAHPRA and Ethics Committees

Site Master File (SMF) compilation


Standard Operating Procedure (SOP) compilation

Artwork and advertising reviews

Contact Us

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Contact info

  • E-mail : nadia@samrac.co.za
  • Phone : +27 72 502 5109
  • Alt-Phone : +27 82 784 5196
  • Web : www.samrac.co.za

Address:

  • Villebois Office Park
  • c/o Jacques Street and De Villebois Mareuil Drive
  • Moreleta Park, Pretoria
  • South Africa