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Life Sciences

We work with commercial and pre-commercial 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.

 

LIFE SCIENCES CONSULTING SERVICES

Clarkston offers a broad suite of services to our clients in life sciences including strategy, innovation, and mergers and acquisition advisory, sales and marketing, supply chain, quality and regulatory, clinical R&D, SAP and technology consulting. In addition to these core service areas, Clarkston helps clients effectively meet the most pressing industry challenges.

Precision and Personalized Medicine

We work with clients to evolve and innovate current manufacturing, distribution, and quality control operating models to meet the game-changing challenges of personalized medicine.

Pre-Commercial Readiness

Clarkston leverages deep industry expertise and recognized functional and business process leadership to help life sciences companies transition from development to commercialization, ensuring sustainable, long-term growth.

Clinical R&D Effectiveness

We partner with clients to reduce R&D timelines and costs to create modern and flexible R&D and clinical trial capabilities that improve efficiency and foster innovation.

Data Integrity

Clarkston helps businesses mitigate data integrity issues to meet regulatory compliance, improve quality operations, and create a platform for evidence-based decision-making.

Quality Systems and LIMS

Clients seek Clarkston as a partner in executing a business-driven, returns-focused implementations of quality systems and LIMS software to drive significant benefits to cost, compliance, and efficiency.

S/4HANA for Life Sciences

At the center of every organization is a technology engine that keeps your business running. Many emerging and established life sciences companies are considering S/4HANA that engine.

Sustainable Training and Change Activation

Sustainable change requires organizational alignment and leadership support. We help your employees create and adopt the change required to support the business of the future.

Program Management

Clarkston manages life sciences programs and transformation initiatives with a level of industry experience and project management discipline you won’t find in common consulting firms.

Interested in Clarkston's Life Sciences Services?

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Life Sciences Experts

Janel Firestein

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.

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Irene Lewis

Irene Birbeck

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.

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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.

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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

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Brajinder Singh

Brajinder Singh

Partner
Brajinder has led global initiatives for LS and CP companies that have included quality systems and ERP implementations, serialization, and regulatory remediation and compliance initiatives.

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Traigh Groover

Traigh Groover

Partner
Traigh lends his broad biotech experience to help life sciences clients develop and actualize new models for operations, commercialization, and technology tailored to advanced treatments in personalized medicine.

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Key Sectors

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

Pharma

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.

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Medical Device

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

Biotech

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.

Generics

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.

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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.

Wholesale/Distribution

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.

View our Featured Life Sciences Insights

Insights

Featured Clients

Mylan
United Theraputics
Gilead Sciences
Novartis
Shire
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Astellas
Recro
Alny
Indivior
Teva