Clarkston Consulting
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Life Sciences

We work with life sciences companies to innovate and drive growth in the face of regulatory uncertainty, pricing pressures, and an evolving industry landscape. As your partner, we develop actionable solutions to address your needs, your stakeholders’ needs, and your bottom line.

How We Help

Life Sciences Experts

Janel Firestein

Partner, Life Sciences Industry Leader
Janel is a recognized expert delivering business results in the areas of regulatory compliance, business process improvement, change management, product development, quality systems, and strategy.


Irene Birbeck Lewis

Associate Partner
Irene specializes in the management of quality systems process and technology implementations within the life sciences, with specific experience in the chemical, pharmaceutical, and biotechnology industries.


Dmitri Serebrianik

Generics Industry Lead
Dmitri has a passion for helping organizations deliver on their strategic goals. He lends his expertise in the areas of quality systems, validation, M&A and project management.

Allyson Hein

Allyson Hein

Medical Device Industry Lead
Allyson lends her expertise in the areas of quality systems operations and technologies, FDA and Health Authority regulation compliance, ISO standards, continuous improvement, and change management


Mike Leary

Mike has led global initiatives for LS and CP companies that have included quality systems and ERP implementations, organizational design, and regulatory remediation and compliance initiatives.


Gary Richey

Pharma, Biotech, and Contract Manufacturing Industry Lead
Gary lends his expertise to leading life sciences clients in the areas of quality systems, business process improvement, change management, technology governance, and IT effectiveness.


Key Sectors

Clarkston Consulting leverages decades of experience in life sciences to remove barriers for leading companies in all industry sectors.


We understand that building and expanding your product brand is top of mind for pharmaceutical companies.  With Clarkston Consulting as your business partner, our team will help you overcome eroding margins, regulatory complexities and shareholder pressures.

Manufacturing icon

Contract Manufacturing

Contract manufacturers need to run a streamlined, profitable business while remaining flexible to client demand. For decades, Clarkston Consulting has been delivering business services and customized strategies to the leading life sciences manufacturers.


Innovation, speed, and agility are critical for success in biotechnology. Clarkston Consulting partners with biotech companies in various development stages to achieve commercialization and embrace agility for future opportunities.


The generics manufacturing industry has grown rapidly over the last decade, saving patients billions of dollars. At Clarkston Consulting, we specialize in mitigating the challenges that come with tremendous growth and can help solve for cost-containment, pricing optimization, and speed to market.

Medical Device

The opportunities for the medical devices industry are rapidly expanding as patient engagement increases. Our team of experts will help your firm master device traceability, serviceability and patient integration.


Achieving consistent success in getting the right medicines to the right patients at the right time requires a highly complex supply chain. Clarkston Consulting helps distributors be the vital link between manufacturers and patients.

Featured Clients

United Theraputics
Gilead Sciences