Bio-Santee Chem 

Bio-Santee Chem offers your company a range of services:

• Cost effective internal Quality /GMP compliance audits, litigation testimony and vendor/supplier inspections.
• Mock-FDA PAI and GMP Inspection of biotechnology, diagnostics, pharmaceutical and API manufacturers.
• QA and QC System Audits.
• Supplier and Vendor audits.
• Other GMP related activities.
• ISO compliance.
• Crisis intervention.
• Monitor Clinical Research Projects.
• In-vitro Diagnostic Research & Development.
• Pharmacoepidemiology for case control, cohort & record linkage studies.
• Pharmaceutical Marketing
• Pharmaceutical Sales
•  Toll Manufacturing, Export and strategy.

Benefits of working with Bio-Santee Chem

• You gain world class expertise to any quality /GMP standard you name ( ISO-9000, EU , FDA, MCA, TGA GMPs),or to your own corporate standards.
• We perform many quality systems audits within companies to highlight departmental and system deficiencies and provide guidance for effective corrections.
• Having worked in 17 countries, we know the local cultures and have surmounted the difficulties to ensure useful and effective audits.
• Effective internal company audits where company politics inhibit an effective audit independent, unbiased, objective Quality Assurance / GMP audits, guaranteed to successfully effect change- top management uses us to gain unbiased pictures of operations and the level of company regulatory risks; middle management uses us when top management is not getting the message.
• Whether its Canada, China, England, Ireland, India, Mexico, Switzerland, or anywhere else, we’ve been there, we know our way around; we know what the local norms are, and how far they are from standards you require.
• We have our own trained independent auditors and contractors all over the world, so we minimize your cost and help to solve your problems as fast as we can.

For further information and discussion, please feel free to contact us at our email address. Please see the contact section.