Services

Donald L. Reynolds PhD & Associates, Inc. offers a wide range of bioanalytical services to Pharma, generic Pharma, Biotech and CRO Clients that can be tailored to meet your specific needs.

We can provide on-site or remote scientific or data resources to meet in-house bioanalytical needs or to resolve issues or manage projects with a contracting partner. We can develop a comprehensive bioanalytical program for your drug candidate, serve as a liaison between your company and a bioanalytical CRO partner, provide method troubleshooting services as needed, and monitor and review method validation and sample analysis activities. Our aim is to verify that methods and data are scientifically sound and accurate, and that the necessary regulatory requirements have been met.

DLR Bioanalytical Consulting can help you identify a suitable bioanalytical CRO partner. We can perform pre-qualification audits, monitor and troubleshoot ongoing projects, and audit final study data to ensure that bioanalytical methods, processes and data generated from the laboratory will be suitable for regulatory submission. We have worked with many US and International bioanalytical CRO’s, both as client partners and Clients.

For CRO Clients, we have provided scientific / technical expertise and training to improve assay ruggedness and increase laboratory efficiencies, provided data review and experimental designs to troubleshoot method development, validation, sample analysis, stability and ISR issues, prepared method development strategies for selected drug candidates, reviewed and revised SOPs, optimized laboratory and business processes, prepared report templates and provided report writing services.

DLR Consulting will provide development, management and/or guidance expertise in the following service areas:

SCIENTIFIC / TECHNICAL SERVICES

Bioanalytical method development and validation for drugs and metabolites
Method transfers and partial validations
Develop and implement method development strategies
Provide remote or on-site bioanalytical expertise to US and International Clients
Determine the root cause for assay issues observed during method development, method validation or ISR, and identify suitable solutions
Identify and minimize potential LC-MS/MS matrix effect issues
Evaluate, recommend and implement strategies for new technologies and automation
Review and critique assay methodology and validation data
Develop and present targeted scientific seminars and training programs

REGULATORY / DATA SERVICES

Identify, evaluate and recommend quality bioanalytical CRO partners
Conduct pre-qualification / due diligence, GLP and OECD audits
Manage Client programs at bioanalytical CROs
Monitor and track ongoing bioanalytical activities at a CRO partner
Perform post study data audits
Perform critical review of method validation and sample analysis data and reports
Develop, review and revise SOPs and laboratory processes
Prepare and review study reports and manuscripts
Develop and present regulatory training programs
Offer complete and accurate English translations of selected regulatory documents published by ANVISA
Offer Client-requested English translation services for ANVISA documents

SCIENTIFIC AND BUSINESS PROCESS SERVICES

Aid start-up, small and virtual companies to assess or build bioanalytical expertise
Serve as a liaison between company and CRO for contracted services
Review bioanalytical and site policies and procedures
Review contracts, method development and sample analysis study plans and protocols
Prepare method development strategies to streamline method development processes
Develop automation strategies
Prepare method development plans for specific drug candidates
Optimize operation and work flow processes
Prepare templates for proposals, work plans and reports
Develop a tracking system to monitor projects, milestones, deliverables and project costing analysis

Seminars and training programs can be uniquely designed to meet your specific Company needs. Additional services may also be available upon request, contact us for additional details.

Testimonials

“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

“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

“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

“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.

“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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