jw van zyl incTransactions and diligence
Surface the regulatory exposure a standard diligence review misses.
In a regulated healthcare target, the exposure that changes the price sits in licences that may not transfer, study obligations that survive completion, and a quality and liability history a general diligence review does not test. The firm runs that regulatory workstream inside the deal.
Who this is for
Investors, manufacturers, strategic buyers and portfolio companies
Typically instructed by: Corporate development · investment teams · in-house legal · portfolio operations
Scope
What can be instructed
- CRO and site-network acquisitions
- Diligence on clinical-research operations, site networks, sponsor contracts and study obligations that survive a transaction.
- Diagnostics, medtech and manufacturing
- Diligence on regulated manufacturing, diagnostics and medical-device operations, including establishment and product authorisations.
- Licences and authorisations
- Whether the licences the business operates under are held by the target, are transferable, and survive a change of control.
- Quality, pharmacovigilance and product liability
- Quality systems, safety-reporting obligations, historical recalls and open liability exposure.
- Data and IP ownership
- Ownership of study data, patient data compliance, and the ownership chain of the target's intellectual property.
- Post-investment governance
- Transaction documentation, warranties and indemnities specific to regulated risk, and the governance arrangements that follow completion.
Before you instruct
What helps the firm assess the matter
- The target and the acquiring entity, for the conflicts check.
- The stage of the transaction and the exclusivity or signing date.
- Whether a data room is open and what disciplines are already covered.
- The scope of the regulatory workstream you need covered.