Compliance & Quality Assurance

Our team of Healthcare engineers who exclusively specialize in federal regulations like 21CFR, USO, ISO and GAMP will provide their expertise to being your quality system into compliance and provides regulatory intelligence to develop new processes and systems. After presenting the FDA consent decree remediation project work that our resources performed at client sites, we became one of the trusted recruitment agencies in the Health care industry in the USA and our reputation among our clients and vendors for delivering quality resources is growing constantly.

• Case Report Forms (CRFs)
• Product information (SPC, PILs)
• Drug Substance Services: DMF, IND, Manufacturing, Import & Exports
• Drug Product Services: NDA, ANDA
• Pre-IND and Pre-NDA meeting with FDA
• Writing and compilation of INDs, NDAs, ANDAs, 505(b) (2) and supplements
• eCTD submission
• Providing the clearances
• Regulatory support for clinical trials, Facility Inspections
• CMC (Chemistry, Manufacturing, Control) and Pre-Clinical toxicology
• Regulatory agency interaction
• Pricing and Market Authorization Approval