Formulation and Product Development

Pharmacorp partners with experts in the pharmaceutical field for product development; including reformulation of existing products and new product development.

Laboratory Services

Pharmacorp partners with accredited laboratories, which offer the following services:

  • Chemical testing
  • Microbial testing
  • Method development and validation reports
  • Stability study management
  • Comparative dissolution studies
  • Technical transfer of analytical methods

Regulatory Services

  • Dossier assessment and compilation for the South African, African and selected international markets
  • Dossier life cycle management and documentation control
  • Conversion of existing dossiers into CTD format
  • Marketing authorisation holder for companies without a SAHPRA licence. This service includes a 24-hour pharmacist support function
  • General regulatory support and compliance
  • Pharmacovigilance implementation and management services
  • Review of promotional material to ensure compliance with legal requirements and marketing code authority
  • Compilation and update of scientific professional information documents and patient information leaflets
  • Compilation and review of Site Master Files (SMF)

Pharmaceutical Quality Management System

  • Cleaning validation (equipment and cleaning – layout and implementation schedule)
  • Periodic Quality Review (PQR)
  • Vendor audits (local and international)
  • Compilation and review of Standard Operating Procedures (SOPs)
  • Compilation and review of quality manual
  • Compilation and review of validation master plan
  • Compilation and review of SMF
  • Review of batch documents to ensure compliance with registration dossier
  • Assistance with the establishment of a new pharmaceutical company – Holder of Certificate of Registration (HCR)

Pharmaceutical Training

Pharmacorp partners with an established pharmaceutical training company to provide focussed training, covering the following topics:

  • Development of personnel, including RP, QA pharmacist, as well as pharmacy assistants and regulatory personnel
  • Dossier compilation and management
  • Adherence to the code of marketing practice
  • Control of printed packaging material
  • Pharmaceutical quality management systems
  • Auditing of vendors
  • Preparation for SAHPRA and SAPC inspections