Who We Are

Donald L. Reynolds, PhD & Associates, Inc. offers a broad range of expertise and services in pharmaceutical drug development, with a primary focus in bioanalytical and pharmaceutical chemistry.

We have more than 30 years of drug development experience with new products and generics, and we have provided bioanalytical expertise to US and International Pharmaceutical and Biopharmaceutical companies, Contract Research Organizations and Institutional Financial Management Clients.

Our company was founded on the principles of honesty, integrity and respect, and our corporate culture was designed to ensure that others are treated the way they want to be treated. Our in-depth experience across all stages of drug development (Discovery Support – Post Approval) enables us to offer expert solutions to address your specific bioanalytical needs from both scientific and regulatory perspectives. In addition, our extensive hands-on experience in both Pharma and CRO environments uniquely qualifies us to expedite development programs for Pharma Clients working with external CROs as well as to enhance expertise, processes and profitability in a contracting environment. We understand the sense of urgency required for you to achieve your Company goals, and we are committed to providing quality services in a timely manner. Offered services encompass the Scientific/Technical, Regulatory/Data and Scientific and Business Process areas.

We have partnered with Juliane Carvalho at Brazil Pharma News to provide complete and accurate English translations of selected ANVISA documents published in the Federal Official Gazette of Brazil. Currently available translation documents are located on the ANVISA Documents and English Translations section, and translation services for other ANVISA documents are available upon request. Please contact us for additional information.

DLR CONSULTING MISSION STATEMENT

To facilitate the timely completion of drug development programs for US and International Pharma, Biopharma and CRO clients by evaluating and improving bioanalytical processes, ensuring that bioanalytical methods are appropriately designed and validated, and that quality bioanalytical study data are generated and accurately reported in accordance with current acceptable global Scientific and Regulatory practices

Testimonials

“I have known and worked with Don for nearly 25 years, in the environments of a big Pharma company, a CRO and as now as an independent consultant. I highly recommend Don because he brings a unique blend of scientific expertise in bioanalytical chemistry, a meticulous work ethic and a high sense of integrity to every job he undertakes.”

Thomas N. Thompson, PhD
President and Principal Consultant
R&D Services Pharma Consulting

“Our company was having issues with ISR and sample reproducibility with a particular bioanalytical method validation. We hired Don to work with our CRO to troubleshoot and solve the problem. He methodically eliminated issues and ultimately resolved the root cause of the problem. With Don’s insight and guidance, the CRO successfully completed the bioanalytical method validation and client sample analysis.”

Sharon Perry
Associate Director, Quality,
ARCA Biopharma, Inc.

“Dr. Donald Reynolds was associated with Lotus Clinical Research Academy to share his knowledge & experience with students and Faculty members. Don is a thorough professional with excellent subject matter knowledge. He is also a meticulous teacher. His classes on various aspects of bioanalytical techniques were enjoyed thoroughly by everyone. His experience in the field of Bioanalytical Techniques is simply marvelous.”

Dr. Arindam Mukhopadhyay
Dean, Lotus Clinical Research Academy Pvt. Ltd.,
Bangalore, India

“Don has been a mentor and friend of mine for over 10 years. We initially worked closely together for a multinational CRO supporting preclinical and clinical bioanalytical programs for the pharma and biotech industry. Now that my colleagues and I operate our own preclinical CRO, I call on Don as an independent bioanalytical consultant, as my “go to” expert when our clients run into bioanalytical issues – with Don advising on methods development and validation, and sample analysis, and performing technical and quality audits for our clients and us.”

Matthew Frick
Director, Business Development,
Xenometrics, LLC

“As a small company, we needed to ascertain the quality of vendors prior to placing work at their facility because we simply could not afford any mistakes. We hired Don Reynolds Consulting to audit a bioanalytical facility for project that was just re-prioritized and placed on the fast track for development. Don provided us a high quality and thorough assessment of our potential bioanalytical laboratory and provided a clean and concise audit report such that the team felt comfortable with placing the work at the facility. Because we were short staffed and did not have the experience to assess this type of laboratory within our group, it was comforting to know that Don with his years of experience could do this assessment for us, enabling us to make the final decision in a timely manner”

Anonymous
Director Project Coordination
(small biotech in the Boston area)

“I have worked with Don Reynolds previously as a colleague and now he consults with my company on bioanalytical projects. Don is a thorough professional with excellent subject matter knowledge. He is detail oriented and provides valuable guidance in managing bioanalytical labs, conducting vendor qualification visits, lab audits, data review, and method development. His experience in this area makes him an asset to any group working with him. I have no hesitation in recommending Don as a bioanalytical consultant.”

Annonymous
Head of Clinical Pharmacology/DMPK,
(Pharma Company in Northeastern US)

Testimonials

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