Our Service & Product Offerings:

Regulatory advice, dossier compilations and submissions:

  • New product dossier compilations in CTD, eSubmission and eCTD for Orthodox Medicines- New Chemical Entities, Biologicals, Biosimilars, Vaccines.

  • Application of CTD, eSubmission and eCTD for Orthodox Medicines- Generics based on Bioequivalence studies, clinical data and biowavers.

  • Application of CTD for Complementary Medicines (CMs)

  • Due diligence on dossier information.

  • Pharmaceutical Variations including full conversations from MBR1 and MRF1 to current eSubmissions and eCTD format.

  • Application for registration approval of veterinary medicines under Act 101 and Act 36.

  • Application for registration approval in Sub-Saharan countries including Namibia, Botswana, Mauritius, Zimbabwe, Angola, Zambia, Kenya, Uganda, Ghana, Nigeria etc.

  • GMO Applications.

 Licence application for applicant for manufacturer, applicant, laboratories, wholesalers (NDOH, SAPC, SAHPRA). & Site Master File compilation & RP role
Application for licence approval for medical device companies.
Clinical trial submissions and protocol review
QMS & Standard Operating Procedures (SOPs).
Auditing of Facilities (cGMP, GLP, GWP, ISO).
Pharmacovigilance and Medical information Services:

  • Compilation of Pharmacovigilance master file (PMF)

  • responsible person for pharmacovigilance for both pre- and post- marketing surveillance.

  • establishing and maintaining the local PV system in accordance with legal requirements, corporate standards and best practice within the pharmaceutical industry.

  • Collect product medical information.

Review and proofreading of labeling artwork. Overall regulatory due diligence of the business.
Marketing Code compliance and Advertising review and approval.
Market Access and Advocacy services:

  • Pricing and Reimbursement Strategies

  • Health Economics

  • Barriers to Access

  • Stakeholder Management

  • Communication and Influence