Regulatory Compliance

• Good Laboratory Practice (GLP) audits
• Good Manufacturing Practice (GMP) audits
• Laboratory Design and Operations
• Quality Systems and Audit
• Standard Operating Procedure (SOP) development

Diagnostic Develpment Services (for 501(k) and PMA Products:

• Design from Product Development to Manufacturing
• Regulatory Development Pathway
• Assay Development and Method Validation
• Technology Assessment; Due Diligence
• "Proof on Concept" Studies
• Pre-clinical Testing: Pre-IND;Pre-IDE

Scientific Communications:

• Medical writing
• Manuscripts
• Technical Reports
• Protocols
• SBIR/STTR grant assistance

Market Research:

• Market information, trends, product research and competitor analysis
• Drug Development Services for BLA and NDA Products: Biologics, Monoclonal & Polyclonal Antibodies, Vaccines.