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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
