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Regulatory Affairs

Services offered by the Department

ACRO provides a range of regulatory services to help clients develop interventions and negotiate the path from conception and discovery, through to the clinic and the market.

Using either ACRO's or the client's Standard Operating Procedures (SOPs), the Regulatory Affairs Department assigns a dedicated team to each project and works according to a client-approved project plan. The structure of the team is flexible so it can be customised to accommodate each client's preferences and meet each project's requirements.

Consulting Services

We work with our clients to ensure regulatory compliance and efficiency of:

  • Market entry for medicines, and complementary health product development plans
  • Clinical trial design and conduct
  • Marketing strategies
  • All regulatory related audit activities
  • Post-marketing maintenance and surveillance
  • Risk management plans for patients and products


Regulatory Services

ACRO ensures that regulatory norms are complied with in the development of medical devices, drugs, biologics, biotechnology products and complementary medicines.

The company provides related services such as:

  • Preparation of submissions at all stages of the development of medical devices, drugs, biologics, biotechnology products and complementary medicines.
  • Submissions on behalf of our clients to local and regional African regulatory authorities
  • Insourcing of regulatory pharmacists


ENQUIRIES

For further information, please contact our team using the information provided below:
Tel: +27 (0)11 470 2800
Email: enquiries@acro.co.za