Regulatory Services

We assist to create and/or evaluate your company’s organisational structure and delegation framework for the Responsible Pharmacist. 

We compile or update Site Master Files, Quality Manuals, Job descriptions and delegation letters. 

We assist to define or implement QMS systems, i.e. Change management, Deviation management, Customer complaint handling, CAPA management.

We conduct self-inspections on existing systems and assist with audit preparation.

Self-regulating industry codes of marketing practice are upheld by various industry bodies/associations and provides for ethical marketing and sales practices by pharmaceutical companies both locally and internationally. These industry bodies are working towards the integration of these codes into the Act and related regulations by SAHPRA.  

We offer training on the practical application of industry codes of practice for the marketing of medicines/medical devices for Compliance Officers or customer-facing employees.

We offer the services of a delegated Compliance Officer in terms of industry Codes of Marketing Practice.

We conduct the review and approval of marketing and product-related material, as well as events, meetings or other interactions with both consumers & HCPs to assure compliance to the requirements of these industry codes. 

We provide the following additional regulatory activity support: 

• Literature searches for content referencing purposes

• Editing & proofreading in English or Afrikaans of Professional Information Leaflets or Patient Information Leaflets

• Translation from English to Afrikaans or Afrikaans to English of Professional Information Leaflets or Patient Information Leaflets

• Evaluation of artwork for product packaging