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BCTS Biomedical Consulting |
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SERVICES Click on the topic for more information. |
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BCTS Biomedical Consulting |
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SERVICES Click on the topic for more information. |
| Consulting Services - Biomedical research studies, including non-clinical studies for pharmaceuticals, biotechnology products, and medical devices, preclinical development programs for IND and NDA submission. Toxicology studies from acute to chronic, and carcinogenicity including safety pharmacology, toxico- and pharmacokinetics. |
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| Project Management - Drug development programs for IND/NDA submissions; laboratory development for non-clinical toxicology, safety pharmacology, clinical pathology, pharmacokinetics, and other in vivo research facilities; GLP programs; and training programs. |
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| Risk Assessment -We can do the research, evaluate the available scientific information and prepare risk assessments for internal or external needs. |
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| Institutional Animal Care and Use Committee - Organization, SOPs, outside committee member participation. |
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| Product Safety Evaluation – Research, review, interpret, and summarize existing safety data on drug or chemical products for decision making and submissions. |
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| Study Design - Determine studies needed and the appropriate design and model including: species; route of administration; duration; numbers; and endpoints to evaluate. Answers to all your questions about conducting non-clinical studies. |
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| Contract Research Vendor Selection – Determine most appropriate contractors for your study needs, site visits, audits, monitoring of studies contracted to vendors. |
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| Computer System Validation – We can help you verify the function of your computerized data collection and document handling programs. |
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| Good Laboratory Practice Regulations – Evaluation, auditing, training, problem resolution in all areas of GLP compliance. |
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| Standard Operating Procedures – Audit your existing procedures, determine weaknesses and deficiencies, develop new SOPs suitable for your unique needs. |
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| Training – GLP-required training in areas of GLP compliance, laboratory operations, writing SOPs, conduct of research studies, and laboratory documentation. |
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| Auditing– We can audit your operation or that of a contract vendor or business liaison in the areas of facilities, data, documents, and compliance. |
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| Document preparation – We can help you with preparation of many types of specialized documents including: risk assessments; protocols; reports; IND, NDA, or PLA submissions; and Expert Reports. |
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P.O. Box 1003, Castroville, Texas 78009
Telephone: 210.383.5280 830.426.4497
Fax: 830.426.4497
E-Mail: e-mail: bcts@biomedicalconsulting.net