CRA’s policy team provides analysis and insights into issues affecting the life sciences industry. We work across global, regional and national policy areas to assess and make recommendations relating to current situations and the potential impacts of proposed policy changes, in support of clients’ strategic priorities.

CRA has a reputation for independence and rigour, benefiting from long standing relationships with most leading pharma organisations as well as national governments and the European Commission and industry associations such as IFPMA, EFPIA, and PhRMA. Our specialist team has provided unique policy oversight for the past 15 years, working closely with our strategy consultants to support clients in achieving their wider corporate objectives. We deliver high quality, robust analysis but in a compelling fashion that is accessible to the target audience, whomever it may be.

Clients come to CRA’s policy team when they want to:

• Evaluate the impact of regulation and how clients can optimise their position accordingly
• Anticipating future changes in the policy environment and the business implications  associated with them
• Develop policy positioning - assessing the cost and benefits of different policy options
• Support government affairs functions in managing and coordinating global policy processes in alignment with commercial priorities of the business
• Influence the macro policy environment at global, regional, and national level through robust evidence development

Specialist policy capabilities

Latest thought leadership

What's The Right Pricing Strategy For Cell And Gene Therapies? >

Litigation in the Pharmaceutical and Medical Device sector >

Biobetters and Regulatory Affairs >

More insights >

Our life sciences practice is made up of 185 consultants that blend decades of global business experience with an extensive understanding of life sciences.

Meet our senior team >

Sample engagements

• Policy analysis – A global pharma company sought insight into the policy implications of variations in access to Multiple Sclerosis treatments across Europe. CRA’s analysis and report has helped the company build its argumentation to policy makers around barriers to effective MS treatment.

• HTA impact analysis – EFPIA & PhRMA asked CRA to describe how HTA systems are evolving and their impact on access to medicines in a range of markets. The study demonstrated that HTAs are increasingly delivered in a more timely fashion but are not enabling earlier access to innovative medicines.

• Reimbursement policy – CRA reviewed reimbursement of orphan medicines across Europe for a pharma company supplying therapies in this sector. A toolkit on reimbursement practices at national, regional and local levels, set out best and worst practices and their consequences, to support argumentation with payers.

CRA’s life sciences litigation support is grounded in a comprehensive understanding of pharmaceutical, biotechnology, medical device, and diagnostic markets. For more than 30 years, our experts have consulted with major life science companies, law firms, and regulatory agencies around the globe, providing the industry experience and analytical expertise needed to solve their most challenging strategic problems and resolve their most contentious disputes.

CRA has a reputation for delivering rigorous analysis and expert testimony that meets the highest standards. Our witnesses are respected for their professional excellence and effectiveness in highly demanding life sciences cases. Our team members have extensive business consulting and litigation experience in the life sciences industries. The academic backgrounds of our consultants are complemented by results-focused, practical experience. This combination allows CRA to apply effective expert testimony and non-testifying expertise to our clients’ most important problems.

Client challenges

Disputes involving

• Antitrust, including reverse payments and delayed generic entry
• Class certification
• Commercially reasonable efforts
• Damages assessment
• Economic fraud
• Government investigations
• Intellectual property disputes and valuations
• International arbitrations
• Off-label marketing and product liability
• Pricing, reimbursement, and distribution
• Transfer pricing policy
• Labor and employment

Latest thought leadership

What's The Right Pricing Strategy For Cell And Gene Therapies? >

Litigation in the Pharmaceutical and Medical Device sector >

Biobetters and Regulatory Affairs >

More insights >

Our consultants blend decades of global business experience with an extensive understanding of life sciences.

Meet our senior team >

Sample engagements

• A global pharma company abandoned a product launch following unfavorable clinical trial results. When their stock price fell, they were sued for allegedly concealing information. The court accepted our analysis/conclusion that information concealment was an unlikely reason for the price change.

• In a matter involving an antitrust counterclaim, a generic pharmaceutical manufacturer alleged that a blockbuster brand manufacturer attempted to monopolize the market and delay entry of the generic product. A CRA expert analyzed market definition, competitive effects, and lost profits damages estimates. The matter settled favorably for our client shortly before trial.