Services provided by BDC's Clients

We have qualified service providers in the following broad catagories. There are further descriptions of each category as you scroll down the page.

• Product development, Non-Clinical, Clinical & Regulatory
• Analytical Laboratories
• Quality, Compliance, C&Q, & Validation
• Strategic & Tactical Consulting from Development to Commercialization

Please let us know if you would like additional information regarding the companies or consultants we represent. We look forward to speaking with you regarding your outsourcing interests and then connect you to the provider that is best suited to meet your needs.

Additional descriptions of each service category

• Drug and Product Development – API synthesis, formulation for all pharmaceutical dosage forms, packaging, and in vitro modeling.
• Analytical - methods development and validation for API and drug product, release testing, stability studies, proteomics biomarker development, bioanalytical methods development, HPLC, LC/MS, and GC/MS methods development.
• Manufacturing – API and drug product GMP manufacturing for Phase I through Phase III clinical supplies.
• Preclinical – study design, protocol development, histopathology, in vitro and in vivo studies.
• Pharmacology and Toxicology – ADME, PK/PD, safety and efficacy, acute and chronic studies, development planning, study design, methods development, protocol development, and histopathology.
• Clinical and Regulatory – study design and management, ongoing study support, identification of study sites, due diligence and study liaison, support, planning, and preparation of CMC, IND, CTA, NDA, and MAA, in vivo and in vitro studies, histopathology, and staff training.
• Quality and Compliance – QA and QC support from development to commercialization, quality system development and assessments, SOP development, internal and external audits, and GLP, GMP, GCP, ISO, QSR, and QA/QC monitoring and training.
• Validation, Commissioning, and Qualification – technical validation for equipment, facilities, utilities, computer systems, and processes; validation master plan preparation and assessment; automation design and validation; risk assessments; TOC analysis; cleaning and software validation.
• Technical Writing – preclinical and clinical study reports, investigative brochures (IB), medical writing, publication planning and writing, market research reports, and CMC and IND planning and writing.
• Strategic Planning – master validation planning, QC/QA compliance planning, clinical indication sequencing, financial strategy, HR strategy, organizational strategy, supply chain planning, and brand, product, and marketing strategy.
• Facilities – site acceptance testing (SAT), factory acceptance testing (FAT), commissioning, qualification, validation, cleanroom maintenance, janitorial services, internal and external audits, automation, calibration, and general maintenance.
• Staffing – temporary, part-time, and full-time staffing for the pharmaceutical, biotechnology, medical device, and diagnostic industries.