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jw van zyl inc

Regulated life sciences · South Africa

The South African legal workstream for pharmaceutical, biotech, medical-device and clinical-research operations.

One senior lawyer, with a decade inside clinical research and pharmaceutical operations before the practice. Engaged for defined projects, transactions and continuing outside-counsel support.

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How clients instruct the firm

Three ways to instruct the firm.

Global and regional life-sciences teams reach a point where a South African agreement, structure or regulatory responsibility has to be resolved locally. JW van Zyl Inc provides that local legal capacity.

A defined project
One scoped mandate with agreed deliverables and a fixed or bounded fee: a market entry, a distributor change, a set of agreements.
A transaction
The South African regulatory and legal workstream inside a deal: diligence, risk allocation, and the conditions the deal cannot leave behind.
Continuing outside counsel
Defined monthly capacity under a recurring mandate, for teams that need South African legal capability without another permanent hire.

When JW van Zyl Inc is engaged

Five situations that bring the firm in.

01

Entering South Africa

Establishing regulated operations from outside South Africa: entity, licensing, distribution structure, regulatory responsibility and the first commercial agreements.

 02

Starting a South African clinical programme

Site activation, sponsor, CRO and site contracting, insurance and indemnity, POPIA, and the ethics and SAHPRA interface for a specific trial or programme.

 03

Changing a distributor or regulatory holder

A structural change to who holds the regulatory position or the supply chain: contract, transition, liability allocation and product responsibility.

 04

Acquiring a regulated healthcare business

Regulatory, contract and IP diligence on a South African healthcare or life-sciences target: surviving obligations, licence transferability and the compliance conditions the deal cannot leave behind.

 05

Temporary in-house legal capacity

A continuing South African outside-counsel workstream under a defined recurring mandate, priced monthly, for teams that need local capability without another permanent hire.
Sectors
Pharmaceutical · Biotechnology · Clinical research: sponsors, CROs, sites · Medical devices & diagnostics · Funded health programmes · Healthcare investors & manufacturers
Regulatory & governance
SAHPRA · POPIA / PAIA · Research ethics & governance · Company & director governance · A Legal Practice Council–regulated practice

How the firm is engaged

A defined scope, agreed in writing before work begins.

Set out the parties, the situation and the deadline. The firm checks conflicts and responds in writing from info@jwvanzylinc.com within two business days.