Question 1

Can we engage Leanabl for only due diligence, or only the transfer execution?

Accepted Answer

Yes. The service is offered in three engagement modes. Due-Diligence Only — a pre-deal regulatory status assessment delivered before binding agreements; the report is yours to act on with any partner. Transfer Execution Only — when due diligence is already complete or the acquirer accepts the existing record, we manage MFDS filings to transfer the license into the new holder's name. Combined DD + Transfer — a single engagement that runs the diligence pre-close and the transfer post-close, with continuity across the same team. The right mode depends on transaction stage and how much regulatory diligence has already been performed.

Question 2

When should RA due diligence begin in a transaction timeline?

Accepted Answer

Regulatory due diligence should begin during the exclusivity or letter-of-intent phase — before binding agreements are signed. Early engagement allows identified risks to be factored into deal terms, purchase price adjustments, or remediation plans that become closing conditions, rather than post-close surprises.

Question 3

How long does an MFDS license transfer take?

Accepted Answer

A straightforward license transfer with complete documentation typically takes 2 to 4 months from MFDS submission to confirmed transfer. Transfers involving additional change notifications, missing documentation from the original license holder, or higher-risk device classes may take longer.

Question 4

What happens to the license if the original holder is dissolved?

Accepted Answer

If the original license holder is dissolved or no longer exists, the license is at risk of lapsing. We manage the regulatory pathway to address this — including the evidence requirements to establish continuity of the license to the new holder — and initiate the transfer process in coordination with the MFDS.

Question 5

Can you assess a large portfolio of licenses for due diligence?

Accepted Answer

Yes. We conduct due diligence assessments for portfolios of any size, including multi-product, multi-manufacturer-site, and multi-device-class portfolios. We prioritize findings by regulatory risk level and deliver a structured report that allows the acquiring party to make informed decisions about the transaction.

License Transfer & RA Due Diligence

A product license tied to the wrong legal entity is a liability, not an asset.

RA Due Diligence

License Transfer Execution

Post-Transfer Compliance Review

Your Complete Transfer & Due Diligence Package

Frequently Asked Questions

The regulatory risk in a device acquisition is often invisible until after the deal closes. By then, it is your problem.