cGMP/GLP/R&D

 Reports

Registrations & Licenses

Chemic Document Control

Document Development

Import/Export Services

Consulting Services

Document Development

•  Validation Protocol Development

•  Translation Services

•  Regulated Documentation Submissions Support Services

•  Review Replies to FDA 483 Observations & Correspondence with FDA

•  Obtain Information under Freedom of Information Act (FOIA)

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