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
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FDA Compliance Consulting
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Project Management
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FDA 483 / Warning Letter
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Consent Decrees
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Systems Monitoring
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GXP Training
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Product Submissions
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Due Diligence
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Product Reviews
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Registration & Listing
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Audits
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Gap Analysis
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Regulatory Strategies
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Inspection Preparation
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GMP Services
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GCP Services
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FDA Submissions
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Clinical Development
- Nonclinical Development
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Risk Based Assessment
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Combination Products
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Staff Augmentation
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Electronic Publishing
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Program Design