How and where your product is produced is critical to efficacy, reliability and safety. Our specialists can guide you through facility registration and listing by identifying existing and/or qualifying manufacturing facilities, and consulting on facility design, construction, system adaptation, and acceptance testing of equipment.
Our team’s capabilities include: assessments of engineering plans, sterilization, laboratory standards, HVAC and environmental controls, dust control systems, processing.
Experience & Capabilities
FDA Compliance Consulting
Project Management
FDA 483 / Warning Letter
Consent Decrees
Systems Monitoring
GXP Training
Product Submissions
Due Diligence
Product Reviews
Registration & Listing
Audits
Gap Analysis
Regulatory Strategies
Inspection Preparation
GMP Services
GCP Services
FDA Submissions
Clinical Development
Nonclinical Development
Risk Based Assessment
Combination Products
Staff Augmentation
Electronic Publishing
Program Design