Providing professional, tailored regulatory, quality and clinical compliance services to entrepreneurs, startup companies, small business entities, academic institutions, emerging technology incubators and venture capital investors committed to the development and commercialization of new and innovative pharmaceutical, biotechnology and medical device healthcare products.
Regulatory, quality and clinical compliance assessment, remediation and management services supporting your product development activities and portfolio investments. A proactive, risk management approach will help minimize product nonconformities and compliance issues that serve to undermine the pathway to commercial product.
These compliance services include, but are not limited to:
Good Clinical Practice Audits
Good Clinical Laboratory Practice Audits
Good Pharmacovigilance Practice Audits
Good Tissue Practice Audits
21 CFR Part 11 Audits
Quality System Audits
Mock FDA Pre-Approval Inspections
Due Diligence Audits
For Cause Audits