Trinity Pharma provides the full spectrum of end-to-end product registration services for international and local principals. As a client you will be assisted and supported in the following ways:

i. Acting as an applicant on your behalf
ii. Providing regulatory support to register dossiers in South Africa
iii. Providing post registration support

ACTING AS AN APPLICANT

The registration process in South Africa is exceptionally strict and may take up to two years to complete. Prerequisites for any international pharmaceutical company wishing to commercialise their products in South Africa currently are, amongst others:

a) To be locally present, i.e. be a registered company with an office in South Africa;
b) To employ a Responsible Pharmacist (as a full-time employee); and
c) To fulfil certain other regulatory infrastructure requirements.

These prerequisites often signify a huge barrier to entry especially for international SMEs, who do not wish to invest heavily in staff and office infrastructure while no return through sales can be generated during the registration process.

Trinity Pharma have a strong track record in successful registrations and over 50 years of in-house regulatory experience. Clients include multinational companies such as GlaxoSmithKline, Bausch & Lomb, Famycare, Torrent and Heraeus.

PROVIDING REGULATORY SUPPORT TO REGISTER DOSSIERS IN SOUTH AFRICA

Given the intricacies of the regulatory requirements, Trinity Pharma consults with local and international principals to advise them on the registration process. Over the years, their regulatory offering has been differentiated by choosing to offer a boutique consultancy experience by limiting the number of clients they take on. This way they are able to ensure the consistency of the high levels of service that our clients are accustomed to receiving.

PROVIDING POST-REGISTRATION SUPPORT

Following the registration of the product, Trinity Pharma continues its oversight of regulatory requirements and ensures that the clients' products are and remain compliant with the South African legislation and policies.

Some of the activities that Trinity Pharma performs in this regard are:

  • Post-registration amendments and dossier maintenance
  • Pharmacovigilance
    • Reporting of adverse events
    • Product withdrawal or recall
  • Marketing and advertising material review and approvals
  • Training of sales representatives
  • Final product release following importation or manufacture
  • GMP compliance
    • Auditing in terms of the GMP requirements for applicants
  • Vendor inspections and approvals


CONSULTING SERVICES

Trinity Pharma strives to make their client's case to enter the African market as sound as possible. Consultancy services include:

  • Regulatory Market Orientation Report - Provision of its clients with the necessary information with regards to processes and procedures that need to be considered and which requirements to fulfil in order to commercialise products in South Africa
  • Cost estimates – Costs during the registration process and cost drivers to be considered after registration for all matters related to pharmacovigilance
  • Market potential assessment – Sizing of the market opportunity
  • Branding and marketing – Marketing support post-registration of the product
  • Logistical support and advice
  • Sourcing & Procurement

You may find detailed guidelines by the South African regulatory authority, the Medicines Control Council (MCC), at the following link: MCC

Regulatory guidelines