cGMP/GLP/R&D

 Reports

Registrations & Licenses

Chemic Document Control

Document Development

Import/Export Services

Consulting Services

Consulting Services

•  Meets Requirements of Designated Agent as per Guidance

Established by the FDA (February 11, 2002)

•  Support Agency Regulated Submissions

•  Mock Pre-Approval Inspections (PAI)

•  Meetings with Agencies (FDA, DEA)

•  Review Process Changes for Necessary Updates to

   Current Submissions

         Value Added Services

*Lauryl Lactate

QC Analytical Services

ICH Stability Programs

Extractables & Leachables Analysis

  Bioanalytical Sample Analysis Methods Dev., & Validation

    cGMP Organic Synthesis  

(kg scale) & Formulations

  CMC Analytical

Development & Validation

Regulatory  & QA Services