Regulatory and Quality Assurance

Regulatory and Quality Assurance

The South African Health Products Regulatory Authority (SAHPRA) and global standards, underpins the regulatory principles used by the team of regulatory and quality assurance experts within Specpharm. These are stringently applied to achieve the goal of Marketing Authorisation of products of the highest quality, safety, and efficacy.

Specpharm enjoys the services of a highly skilled regulatory and quality team with over 100 years of combined African Regulatory experience, expertise, tools, leadership skills, insights, and successes. The regulatory and quality assurance team has been carefully selected based on their multiple achievements in gaining market access for renowned pharmaceutical products spanning a variety of therapeutic areas, within multi-national pharmaceutical and prominent generic companies in Africa.

The Specpharm regulatory and quality team has a deep and nuanced knowledge of Pharmaceutical Laws and Regulations on the African continent.

Regulatory speed and agility is of the essence in gaining rapid market access. With the necessary skills within Specpharm, the regulatory team has the expertise to navigate an expedited registration process.

The Specpharm regulatory team ’s expertise lies in not only ensuring the prompt delivery of initial dossier submissions for rapid market authorisation, but they also understand the importance of dossier submission maintenance to guarantee its life-cycle beyond the period of approval.

The deployment of our internal core competencies supports this, for various Regulatory Authorities in Sub-Saharan Africa, to assist in expediting approvals and post-marketing surveillance.