In this episode of Covington’s Life Sciences Audiocast, Mosa Mkhize and Grant Castle discuss developments in the African Medicines Agency and regulatory convergence.

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Photo of Mosa Mkhize Mosa Mkhize

Mosa Mkhize is a policy advisor and leads the firm’s Africa Public Policy Practice. Drawing on her experience both in government and in various roles in the private sector, Mosa provides strategic policy and regulatory advice to clients doing business with and across…

Mosa Mkhize is a policy advisor and leads the firm’s Africa Public Policy Practice. Drawing on her experience both in government and in various roles in the private sector, Mosa provides strategic policy and regulatory advice to clients doing business with and across Africa. Mosa does so by leveraging close to two decades of experience in international trade, public policy and government affairs.

Mosa assists clients on a broad range of issues including advocacy, strategic policy, regulatory, and dispute resolution advice in various sectors, including technology, energy and life sciences. In addition to this, Mosa’s capabilities include building strategic relationships and coalitions in support of smart technologies. Furthermore, she is currently working with government officials, private corporations, academia, and the general public on the development of regulations and policies that will bring about an enabling environment for digital transformation and economic growth in Africa.

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Photo of Grant Castle Grant Castle

Grant Castle is a partner in London, Brussels, and Dublin practicing in the areas of EU, UK, and Irish life sciences regulatory law. He supports innovative pharmaceutical, biotech, medical device and diagnostics manufacturers on regulatory, compliance, legislative, policy, market access and public law…

Grant Castle is a partner in London, Brussels, and Dublin practicing in the areas of EU, UK, and Irish life sciences regulatory law. He supports innovative pharmaceutical, biotech, medical device and diagnostics manufacturers on regulatory, compliance, legislative, policy, market access and public law litigation matters in the EU, UK, and Irish Courts.

He is one of the Co-chairs of Covington’s Life Sciences Industry Group and is Head of Covington’s European Life Sciences Regulatory Practice.

Grant regularly advises on:

  • EU and UK regulatory pathways to market for pharmaceuticals and medical devices, including in vitro diagnostics and on associated product life cycle management;
  • Pharmaceutical GxPs, including those governing pharmacovigilance, manufacturing, the supply chain and both clinical and non-clinical research;
  • Medical device CE and UKCA marking, quality systems, device vigilance and rules governing clinical investigations and performance evaluations of medical devices and in vitro diagnostics;
  • Advertising and promotion of both pharmaceuticals and medical devices; and
  • Pricing, reimbursement and market access for both pharmaceuticals and medical devices.

Grant also handles procedural matters before EU, UK and Irish regulators and UK and Irish market access bodies, where necessary bringing judicial reviews for his life sciences clients before the EU, UK and Irish Courts.

Chambers UK has ranked Grant in Band 1 for Life Sciences Regulatory for the last 21 years. He is recognized by Chambers UK, Life Sciences as “excellent,” “a knowledgeable lawyer with a strong presence in the industry,” who provides “absolutely first-rate regulatory advice,” according to sources, who also describe him as “one of the key players in that area,” whilst Chambers Global sources report that “he worked in the sector for many years, and has a thorough understanding of how the industry ticks.” He is praised by clients for his “absolutely first-rate” European regulatory practice. Legal 500 UK notes that he is “highly competent in understanding legal and technical biological issues.”

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