Michael James MealyPharma Consulting

Independent pharmaceutical consulting

Technical clarity.
Before the deal.

Understand the science, manufacturing realities and evidence behind an API acquisition.

Independent technical due diligence for M&A and product acquisitions, connecting data-room detail with the decisions that matter.

Explore M&A diligence How I work
API / DRUG SUBSTANCETECHNICAL DUE DILIGENCE
Stainless steel process vessels with pressure gauge, valves and connecting pipework in an industrial interior
From process detail
to acquisition perspective.
Illustrative process vessels and pipework.
Policarpo Brito / Pexels · Image credits
Specifications & analytical dataManufacturing & scale-upCOGS & process economicsQA & data-room review

The acquisition question

What is proven.
What needs a closer look.

A process description is a starting point. The evidence behind it is what makes a technical assessment useful.

I bring experience in API and drug substance technical due diligence to the review of specifications, analytical data, manufacturing processes, scale-up, cost of goods and quality documentation.

The aim: a clear account of technical findings, information gaps and the questions to resolve before a decision.

See the review scope

A practical way to work

Focused questions.
Traceable conclusions.

Every engagement starts with the decision you need to make and the information available to support it.

  1. 01

    Define the question

    Agree the transaction context, review boundaries, priority risks and reporting needs.

  2. 02

    Examine the evidence

    Review the data room and supporting technical information; identify inconsistencies and missing evidence.

  3. 03

    Make the findings useful

    Set out observations, implications and follow-up questions, with assumptions and limitations visible.

Clean-team participation is subject to agreed eligibility, conflict checks, access controls and counsel-led disclosure rules.

Laboratory beakers, a conical flask and a pipette on a workbench
Illustrative laboratory photograph. Photo credits

Experience behind the assessment

A manufacturing perspective.
A chemist’s attention to detail.

Technical review informed by experience across the full journey: chemical development, scale-up, plant implementation and full-scale routine manufacturing.

My experience spans kilo-lab work, pilot operations at 50–600 L, plant implementation and full-scale routine manufacturing. It also includes work supporting early Phase I/II and 28-day toxicology material.

That background informs the questions I ask of a process: what has been demonstrated, what changes with scale, how the process performs in routine manufacturing, and which assumptions need further evidence?

My scientific publications appear under the name Michael J. Mealy.

Michael James Mealy · Background on LinkedIn

Experience described here is historical. Engagement scope and responsibilities are agreed individually.

Designed for a specific decision

Acquiring a business, a product
or a manufacturing capability?

Explore how a focused technical review can support your transaction team.

M&A / API manufacturing diligence

A focused first conversation

What do you need to
understand before you commit?

Start with the transaction type, the technical questions and the decision timeline. Keep the first enquiry non-confidential.

Discuss a potential engagement

Agree the fit, scope and confidentiality arrangements before sharing technical documents.

Email an enquiry

contact@michaeljamesmealy.com

The link opens your email app. Please keep initial enquiries non-confidential.