Practical Compliance for Innovative Companies

Whitelaw Compliance Group focuses on smaller pharmaceutical, biotech and medical device companies.  We believe that from humble acorns mighty oaks will grow.  We also know that every company needs access to high quality, practical compliance that fits the company's needs and grows as the company grows.  Doing this requires deep expertise and innovative thinking. 

Focus

Built on Deep Expertise and Broad Experience

tools

Our expertise is deep and our experience broad.  With over 25 years working in life sciences and having designed, built and run 4 compliance programs from a "blank sheet of paper", we know from experience what works.  We also know how to fit the pieces together to get things done as quickly and efficiently as possible to minimize disruption and costs.  This gives us the ability to create innovative, effective compliance.

Making All the Difference for Our Clients

Therefore, we offer a range of services tailored specifically to each client's individual needs.  These include:

clients

Compliance vision and risk strategy for the present and future
Program health-checks and CIA readiness assessments
Board of Director expert services, training, and support
Interim department staffing
Policy and SOP development
Process development and execution
HelpLine creation and management
Investigation process development and execution
Staff training and knowledge enhancement
Regulatory response and remediation

 

Papers & Presentations

Whitelaw, Seth, and Fiorentino, Nicodemo and O'Leary, Jennifer, Drug Pricing - The Next Compliance Waterloo (February 21, 2018). 44 Mitchell Hamline L. Rev. (2018 Forthcoming). Available at SSRN: https://ssrn.com/abstract=3127733

PRESENTATION:  Industry at a Crossroads: Legal and Ethical Considerations of Selling Pharmaceuticals in 2016 given at Mitchell Hamline's Health Law Institute

New Approaches:  Focused Monitoring for Smaller Companies

WEBINAR:  Transforming Medical Affairs with fact-based solutions and improved compliance

MAKING THE CASE: The Imperative for Life Sciences Companies to Integrate Corporate Compliance and Quality Compliance