DLR Bioanalytical Consulting

Donald L. Reynolds, PhD & Associates, Inc. (DLR Bioanalytical Consulting) 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 we strive to treat others 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 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 offer 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 goal 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

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.