Facility Registration & Listing
SET UP SHOP
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