consulting

Choose by Areas:

Our consulting services are offered in an assortment of areas. You could opt for our services if you have a requirement in any of these consulting areas:

  • 21 CFR Part 11
  • Analytical Development and Formulation, Drug Process Development
  • Audit Preparation
  • Bianalytical method development
  • Bioresearch
  • Clinical Research / Drug-Device Development
  • Clinical trial
  • Contract Manufacturing Compliance
  • FDA Audit & Inspection
  • FDA quality system
  • Food Safety
  • GCP compliance
  • Global Regulatory Submission
  • Immunogenicity and Bioassay Method Development
  • IND, IDE, CAPA, GMP/cGMP Compliance & PMA's
  • ISO 13485/EN46000 and ISO 9000
  • Laboratory Testing
  • Lean Manufacturing
  • Manufacturing, Packaging and Labeling
  • Microbial control in Clean rooms and other critical environments
  • Microbiology and sterilization
  • Operational risk management, risk frameworks
  • OSHA and MSHA litigation
  • Pre-marketing tPost-marketing
  • QMS Process & Maintenance
  • Quality and process development
  • Quality Systems and Laboratory Controls
  • Risk Management
  • Software Validation/Verification
  • Supply chain development and management
  • Toxicology
  • Water systems, sterilization, aseptic processing

Contact Us

Toll free: +1-800-447-9407
Fax: 302-288-6884
Email: Customer Support

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