Associate Industry Clinical & Regulatory Strategic ConsultingBoston, MA
ThinkQuality, LLC is an innovative consulting firm providing clients across the life science ecosystem with practical customized strategies, solutions and coaching to address a wide array of quality and regulatory compliance-related challenges and opportunities.
Based in the greater Boston area, ThinkQuality, LLC applies over 25 years of its founder’s extensive insights into the complex and global rigors of small and large organizations from early stage discovery through critical development milestones to product approval/launch and beyond – drawing on over 10 regulatory product approvals (from Lipitor to Linzess) and many more investigational and commercial products for numerous therapeutic categories and delivery systems.
Delivering regulatory compliance is one aspect of ThinkQuality, LLC. But, ThinkQuality, LLC offers much more than just delivering on SOPs, audits and other GXP compliance needs.
What differentiates ThinkQuality, LLC is our approach to integrating quality and regulatory compliance matters proactively, strategically, relationally and as value into a client’s business plan for achieving predictability, patient needs and business success. This approach involves
Anticipating – Identifying – Resolving (“AIR”)
potential issues before they become significant pain points for your organization with the FDA, investors or other key stakeholders. Unexpected issues will always arise. For those sticky issues the approach is to minimize potential damage to value and reputation quickly and effectively.
Whether you are a start-up or well established, it’s never too early or too often to be asking “how well do we understand our product/process/stakeholder needs”, “how well do we understand our risks” and “how well are we prioritizing our risk mitigation”. For example:
• Most are aware of the potential impact of a product recall or interruption in supply chain, but have you considered what preventative measures you could be taking to reduce those risks?
• As a start-up, most are aware of the Valley-of Death, but have you considered what you can be doing with limited time and funding to raise your predictability and enhance your value to potential investors? • Most are aware of the rise in data integrity issues being reported across the GXPs and the potential impact to derailing studies, but have you considered what measures you can be taking to maintain both your fast-paced opportunity and your public reputation?
• Many are now receiving FDA fast-track, orphan drug and/or breakthrough therapy designations, but are you prepared to meet significant development milestones at warp-speed without any delays especially since patients are waiting and these designations become closely linked to funding strategies?
Quality is not a spectator sport. And at ThinkQuality, LLC we are committed to working collaboratively and cross-functionally with our clients - engaging scientists and C-level executives as appropriate. All clients have a common challenge – few resources and even less time to spare. ThinkQuality, LLC works with clients to deliver on-time and on-budget – creating a competitive advantage for your specific business
ThinkQuality, LLC is a champion for science-based risk management, proactive and collaborative problem solving, quality-by-design, and organizational design and effectiveness. ThinkQuality, LLC is also vested in working with industry, academia and regulators to advance Quality education and innovation.
Please call or contact us at email@example.com to learn more about our services and expertise. Our collaboration begins with a discussion of your specific business challenges and opportunities and how ThinkQuality, LLC and “AIR” can make a difference.