Facility Registration & Listing

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

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