Our integrated services turn your life sciences goals into reality

"The team played an integral part in the project that ultimately led to the launch of Daybue (trofinetide). They demonstrated expert knowledge of the entire cold chain process and gave us advice, guidance and assistance that facilitated us to get FDA approval. We can’t thank them enough and look forward to working with them in the future."

“Annexon is excited to see that ToxStrategies LLC and Clintrex Research LLC are now operating under one umbrella as part of BlueRidge Life Sciences (BRLS). Bringing experts in the non-clinical and clinical space under one umbrella offers clients unparalleled expertise in this space. ToxStrategies has developed and implemented the non-clinical strategies for Annexon since 2014 on all of our key programs. This includes multiple unique modalities and routes of administration in a variety of complement-mediated diseases Likewise, Annexon has been working with Clintrex since 2018 on clinical development and regulatory strategy challenges for our lead programs, which overlap with those that ToxStrategies has supported. The level of expertise, dedication, out-of-the-box thinking, and solution-oriented approach on both teams has been first in class."

“We’ve had the pleasure of working with Clintrex, a BlueRidge Life Sciences Company, for over three years, and they’ve truly become invaluable thought partners in our journey to develop our Parkinson’s medication. Their expertise has been a game-changer in helping us map out a clear development pathway, from interpreting complex clinical and preclinical data to providing sharp insights that keep us on track. Beyond that, they’ve been hands-on with our Phase 2 and 3 studies—running the enrollment authorization committee, digging into anomalous data checks, and just being an all-around great addition to the team. When we’ve needed them, they’ve also stepped up with smart, reliable regulatory strategy support. BlueRidge Life Sciences doesn’t just deliver; they elevate everything we do and are a great partner who has been invested in our success.”

Craig Thompson, CEO

“Nature’s Own Source, LLC and Duck Creek Energy, Inc have been working with BlueRidge Life Sciences ToxStrategies engineers and scientists for over ten years across multiple disciplines including Radiologic Risk Assessment and Environmental Risk Assessment, and the team provides quality risk assessment and support. Their evaluations have led to successful guidance, direction and outcomes. We appreciate the quality of support and service received with our long-term relationship.”

David Mansbery, President

“ToxStrategies, a BlueRidge Life Sciences Company has been a valuable technical and compliance resource to help Novelis maintain compliance with internal and external environmental regulations and accounting standards. Their technical project reviews have helped drive compliant, sustainable strategies towards project closure.  They have also been a valued resource for Novelis’ financial accounting team to complete accounting standards.  ToxStrategies’ team are a pleasure to work with and bring value-added insights to help maintain compliance and complete our sustainability vision.”

Jeff Drzewiecki, Environmental Remediation Manager

“When Ovid’s vision expanded into brain diseases more broadly, we needed a deeply experienced partner to help us develop a creative clinical and regulatory strategy across our pipeline. I have worked with Clintrex for nearly ten years through several companies and immediately reached out to the Clintrex Managing Principal, Karl Kieburtz, MD  to put into place a relationship with Clintrex. Over the past year, their level of experience, depth and breadth of clinical and regulatory knowledge, flexibility, dedication, innovative thinking, and solution-oriented approach has been remarkable and has contributed to rapid progression of our clinical programs. We have recently expanded this relationship to include experts at ToxStrategies, who are helping us shape our non-clinical studies for success. Clintrex and ToxStrategies have become a critical part of our teams. This group is not just smart and experienced, they are good, curious, open-minded people with high integrity.”

Amanda Banks, Chief Development Officer

“Since 2016 the BlueRidge Life Sciences Clintrex team has been supporting PhotoPharmics® with our clinical development program, regulatory strategy and securing investors for our FDA Breakthrough product, Celeste® specialized phototherapy for both motor and non-motor symptoms of Parkinson’s Disease and for future treatment in Huntington’s and Alzheimer’s. They have become an integral part of the PhotoPharmics team, whether it is solving complex clinical and regulatory challenges, explaining the science and clinical outcomes of our novel therapy to investors, or introducing us to clinical, scientific and industry contacts. The level of expertise, depth and breadth of clinical and regulatory knowledge, flexibility, dedication, out of the box thinking, and solution-oriented approach has been remarkable.  With the support of the Clintrex team we look forward to successfully completing our FDA pivotal trial, receiving FDA and CE market authorizations and providing access to Celeste to improve the lives of patients throughout the world.”

Kent Savage, CEO

"Our BlueRidge Life Sciences regulatory consultant's expertise has been invaluable in navigating the complex FDA landscape. Their deep understanding of regulatory process and strategic guidance has streamlined our medical device approval process, saving us time and mitigating risks. With their support and guidance, we are confidently advancing our product towards First in Human, while ensuring full compliance with FDA standards."

Mike Benjamin, CEO & Executive Board Chair

"We brought the team in as expert consultants during the pre-clinical phase of the development of our lead program. They provided essential insights into the interpretation of our data. We retained them for the design and conduct of our Phase Ia clinical program, and their input during discussions with the FDA was critically important. The successful enrollment and final study results from the first-in-man study of SER-214 in Parkinson's patients have positioned our company for continued success. We are now advancing our next Parkinson’s candidate with this team. They are simply the best."

“Over the past 4 years ToxStrategies, a BlueRidge Life Sciences Company has managed, as our client representative, a complex decommissioning and cleanup of a large, closed steel plant. They have expertly provided strategies, contractor oversight, and coordination and approval of plans under multiple regulatory programs, compliant with regulations, and protective of human health and the environment. We have been very pleased with their work and solution-focused approach. Thank you for the great work!”

Daniela Rost, General Counsel