Terra has established several pharmaceutical specialty services to support expertise in regulatory affairs and navigation of the FDA approval process for medical devices, sterile drugs, and other FDA regulated products.

Terra's expertise embodies a history of securing FDA IDE approvals and presenting the necessary documentation or evidence to meet the FDA's stringent standards. We can provide a complete support network for 510(k) clearances, de novo classifications, Premarket Approval (PMA) applications, and CE compliance for European regulations.

Terra offers an excellent track record for service of private and public sector agencies. We are committed to providing a quality solution with modest fees and end-to-end servicing with a personal touch. Our teams include industry-leading experts and decades of expertise in areas such as pharmacy administration, pharmacy law and regulation, issues management, risk management, modeling of healthcare delivery, and patient safety/quality improvement.

Terra's USP Pharma services extend to off-site educational consulting that aims to enhance the understanding of best practice guidance, particularly in support of pharmaceutical compounding spaces. Terra's in-house engineering teams can provide support for the review of your current and proposed renderings, construct preliminary design drafts, provide equipment recommendations, and advise on air filtration systems or HVAC specifications to ensure function and compliance.

• Compliance with Section 503A
• Mock FDA Inspection for 503A Compounding Pharmacies
• Compliance with Section 503B
• cGMP Compliance Assessments
• Mock FDA Inspections (utilizing FDA's six-system approach)
• FDA Form 483 Response and Interpretation
• Review and Interpret FDA Form 483
• Consulting on appropriate response for Plan of Correction

Terra Universal specializes in USP compliance for both cleanrooms and their associated facilities, providing both on-site and off-site support to ensure that new builds or remodel projects meet or exceed USP standards for chapters <795>, <797>, and <800>. On-site compliance assessments involve a thorough lab evaluation, including staff competency, policy and procedure reviews, testing and documentation requirements, quality assurance, performance improvement, and storage and handling practices.

Terra's cleanroom systems and equipment are engineered to meet and exceed virtually any widely adopted regulatory framework. In the initial design stages, Terra works to align the cleanroom's preliminary designs with the end-user's specifications and prevailing industry norms. This involves the selection of suitable materials, HVAC configurations, filtration systems, equipment outfitting, and spatial planning.

Cleanrooms & Solutions

BioSafe® Modular Cleanrooms

BioSafe® cleanrooms meet ISO 4 - 8 requirements for a sterile processing environment. Designs for single-pass, recirculating, or negative-pressure containment

USP 797 / 800 Compounding

Terra's All-Steel Pharmaceutical Cleanrooms include double-wall, all-steel, gapless panels that minimize cracks, gaps, and crevices where germs collect and colonize.

BSL-Rated Biological Containment

Cleanroom classifications include BSL-2, BSL-2+, BSL-3, ABSL-3, and BSL-4 with modular construction. Globally honored pricing, pre-assembled, and tested before delivery.

Modular Hardwall

Terra’s hardwall modular cleanrooms provide a completely enclosed, rigid freestanding structure with positive-pressure air exhaust vents.

Traditional Stick-Built

Built-to-order designs for life science applications, such as bio/pharmaceutical applications that require a clean, sterile environment

BioSafe® Hybrid Modular

Pre-fabricated coving panels, modular assembly, and stick-built aesthetics for hermetically sealed wall-to-floor and wall-to-ceiling conversions

Extended Services & Expertise