Large Molecule Bioanalysis Scientific Consulting
Eurofins Pharma Bioanalytical Services functions in tandem with our large molecule clients worldwide to provide the expertise and experience required in conducting and reporting new drug clinical study results to regulatory agencies. Our team offers a wide range of consulting services in support of proposed and ongoing large molecule bioanalysis.
Our key strength is our technical expertise, particularly in the large molecule GLP testing space, extending across a diverse type of analytical platforms. Our capabilities are also supported by our quality and regulatory expertise with over 15 years of experience in this specific area of testing services.
We are dedicated to meet the needs of customers with an emphasis on the design of large molecule bioanalytical programs. With our extensive scientific, technical and regulatory expertise in conducting studies in both the US and EU, coupled with our global presence; our consulting team is uniquely qualified to provide clients with the reliability they can trust.
Extensive List of Consulting services includes:
SCIENTIFIC / TECHNICAL SERVICES
- 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 and identify suitable solutions
- Identify and minimize matrix effect issues
- Evaluate, recommend and implement strategies for new technologies
- Review and critique assay methodology and validation data
- Develop and present targeted scientific seminars and training programs
REGULATORY / DATA SERVICES
- Conduct pre-qualification / due diligence, GLP and OECD audits
- Monitor and track ongoing bioanalytical activities at a sponsor 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
- 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
- Prepare method development plans for specific drug candidates
- Prepare templates for proposals, work plans and reports
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.