product-registration
lisence
Training
compilation
Medical-devices

About Us

Who We Are

Peta Healthcare Consultants established in 2013 with 29 years of industry experience. We are a B-BBEE Level 1 contributor with 100% black female ownership. Our dedicated team provides a comprehensive assortment of compliance and regulatory services to the national and international pharmaceutical industry, including Sub-Saharan Africa.

 

Regulatory affairs consultancy and registration services include, but not limited to:

  • Compilation of new product registrations viz. New Chemical Entities (NCEs), generics, complementary medicines, veterinary medicines, medical devices, biologicals and biosimilars.
  • Compilation of amendments/variations and renewals
  • Development of Professional Information (PI) and Patient Information Leaflet (PIL) and safety updates to PIs and PILs post-registration
  • Assist with licence applications (SAPC, DOH and SAHPRA) and compilation of Site Master Files
  • Assist with GMP inspections of manufacturing, packaging facilities and warehouses to ensure compliance

 

Peta Healthcare Consultants is also involved in the supply of medical devices, training and placement of pharmacy personnel in the pharmaceutical industry.

The founder and director of Peta Healthcare Consultants; Dr Dorcas Peta is a qualified pharmacist registered with the South African Pharmacy Council (SAPC). She holds a B.Pharm. degree from the University of Limpopo and a Pharm-D degree from the University of Minnesota in the USA. She is registered as an Assessor and Moderator with SAPC, qualified to teach new entrants into the Regulatory Affairs Arena.

With 29 years of experience in the Pharmaceutical Industry, Dr Peta has extensive experience and understanding of both the pharmaceutical industry and the RA environment. Previously; she was the chairperson of Southern African Pharmaceutical Regulatory Affairs Association (SAPRAA) for 4 years and represented her previous company, MSD in industry associations, ARN and IMSA, in shaping the regulatory environment.

She currently holds affiliations with the Southern African Pharmaceutical Regulatory Affairs Association (SAPRAA), South African Association of Pharmacists in Industry (SAAPI) and Black Pharmaceutical Industry Association (BPIA).

Dr Peta has successfully provided service to many pharmaceutical companies, local and international companies and was previously an external evaluator for the South African Health Products Regulatory Affairs, SAHPRA (previously MCC).  She has been re-appointed as an evaluator by SAHPRA for the Backlog Project. A successful entrepreneur with a well-defined strategic vision.

Services

Compilation of new product registrations viz. 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
  • Assist with Certificate of Pharmaceutical Product (CPP) applications for registrations in other African countries
  • Assist with response to Health Authority (HA) recommendations

Compilation of safety updates to Professional Information (PI) and Patient Information Leaflet (PIL).

  • Review safety updates to Professional Information (PI)
  • Compilation of safety updates to PIs, PILs and Labels to align with current Company Core Data Sheet (CCDS), current Regulations and Acts and current reference books and literature references
  • Assist with response to Health Authority (HA) clinical committee recommendations on PI and PIL safety updates

Compilation of amendments/variations and renewals.

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

Assist with licence applications (SAPC, DOH and SAHPRA) and compilation of Site Master Files

  • Assist with licence applications for 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 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.

  • We assist with self-inspections of companies
  • We provide auditing services of third party manufacturing, packaging, warehouses and distribution facilities
  • Compile pre-inspection/audit reports

Supply of Medical Devices

  • We supply medical devices and in-vitro diagnostics to Hospitals, Clinics, Pharmacies and Laboratories
  • Assist with the 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)

Training

Placement

  • We assist pharmacist or Regulatory Affairs personnel to find position in the pharmaceutical industry

Portfolio of Evidence

Contact Us

Contact Us

Email: info@petahealthcare.co.za
Mobile: +27 71 879 6157
               +27 83 683 3792
Tel: +27 12 655 2089

 

Address

87 Markotter Street
The Reeds
Centurion, 0158

 

Postal Address

P.O. Box 4173
The Reeds
Centurion, 0158