Hours: Mon – Fri 08:00 – 17:00 | t. +27 12 655 2089 m. +27 71 879 6157 | e. dorcas@petahealthcare.co.za
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Our Services

At Peta Healthcare, we are committed to providing professional services ethically and reliably. We pride ourselves on efficiency and quality work, while dedicating ourselves to continuous improvement to ensure accuracy and prompt delivery.

COMPLIANCE AND REGULATORY AFFAIRS

Compilation of new
product registrations

New Chemical Entities (NCEs), generics, complementary medicines, veterinary medicines, biologicals and biosimilars

  • Conduct due diligence on the dossier and compile a deficiency list
  • Compile a dossier for application for registration according to current requirements
  • Assist with response to Health Authority (HA) recommendations 

Compilation of, and safety
updates to, PIs and PILs

Professional Information (PI) and the Patient Information Leaflet (PIL)

  • Compile PIs and PILs for new product registrations
  • Review and compile safety updates to PIs and PILs to align with current Company Core Data Sheet (CCDS), current guidelines, regulations and Acts, and current reference books and literature references
  • Assist with responses to clinical committee recommendations on PI and PIL safety updates.

Compilation of amendments
or and renewals

  • Review the amendments and/or variations by checking current dossiers and proposed changes against the guidelines
  • Compile amendments and/or variations according to the amendment/variation guidelines
  • Assist with the compilation of registration renewals, where required
  • Assist with response to Health Authority (HA) recommendations on amendments or variations and renewals.

Assistance with licence
applications (SAPC, DoH and
SAHPRA) and compilation of
Site Master Files (SMFs)

  • Assist clients with licence applications for manufacturing, distribution, and warehousing of health products (orthodox medicines, complementary medicines, health supplements and medical devices) with South African Pharmacy Council (SAPC), Department of Health (DoH) and South African Health Products Regulatory Authority (SAHPRA)
  • Assist with compilation of Site Master File (SMF) according to SAHPRA guidelines
  • Assist clients with response to queries raised by Health Authorities.

Assist with GMP inspections
of manufacturing, packaging
facilities and warehouses to
ensure compliance

Companies involved in the manufacturing, packaging, sale, and supply of regulated health products require approvals in the form of licences to conduct their operations.

  • Assist with self-inspections of companies preparing for GMP inspections
  • Provide auditing services of third-party manufacturing, packaging, warehouses, and distribution facilities
  • Compile pre-inspection and audit reports
  • Assist clients with response to queries raised by Health Authorities during inspections.

SUPPLY OF MEDICAL DEVICES

We supply medical devices and in-vitro diagnostics to Hospitals, Clinics, Pharmacies  and Laboratories. Additionally, we:

  • Assist with licence applications to manufacturer, import, export, distribute and wholesale medical devices and in-vitro diagnostics (IVDs)
  • Assist with the registration of medical devices and in-vitro diagnostics (IVDs).

RECRUITMENT AND TRAINING

  • Assist pharmacist or Regulatory Affairs personnel to find positions in the pharmaceutical industry
  • Through our affiliation with Quad Pharma, we train pharmacists and non-pharmacists who want to pursue a career in Regulatory Affairs.

To find out more about the training programmes on offer, learn more about Quad Pharma

FIND OUT MORE

Portfolio of Evidence