Terra Consulting & Expertise
Navigating state and federal regulations is a complex undertaking, particularly for organizations managing multiple state licenses across various facilities. Terra offers tailored consulting services designed specifically for the pharmaceutical and healthcare industries, leveraging deep expertise in clinical operations, program development, and regulatory compliance. Our team will help you overcome challenges, address barriers to growth, and ensure compliance for operations nationally and abroad.
Clinical Research
Comprehensive service packages for various stages of clinical research, including initial human trials, early testing, low-risk studies, major trials for regulatory approval, and studies focused on product usability and post-market analysis.
State Licensing Solutions
Our specialists comprise years of expertise in pharmacy administration, pharmacy law, state-to-state board of pharmacy regulation, risk management, delivery modeling, and patient safety/quality analysis.
Hospitals & Healthcare
Integrated project delivery and BIM (software modeling) throughout the project lifecycle ensures initial construction caters to your immediate needs, and defines a clear roadmap for future expansion or modification.
Laboratory Qualification
On-site compliance assessments involve a thorough lab evaluation, including staff competency, policy and procedure reviews, testing and documentation, quality assurance, and storage and handling practices.
Healthcare Consulting
Terra streamlines healthcare facility planning to include efficiency benchmarking, space utilization studies, code compliance assessments, and layout optimization
CGMP Validation
Full cGMP documentation packages offer periodic re-qualification for FDA programs. All validation services are thoroughly documented and undergo quality assurance review before delivery.
Pharmaceutical & Biotech Compliance Specialists
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.
Research and Drug Development Commissioning
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.
Pharmaceutical & Healthcare Consulting
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.
GMP/FDA/GLP Hybrid Modular Cleanrooms
Terra's Hybrid Modular Cleanrooms are both flexible and scalable, accommodating a variety of utility connections including compressed gas, vacuum, plumbing, phone, and Ethernet lines. This flexibility ensures that the wall systems can be tailored to specific operational needs, making them suitable for a wide range of cleanroom applications.
- Interlocking honeycomb wall panels lined with BioSafe® uPVC substrate
- Extruded interlocking aluminum side pieces designed for hermetic sealant
- Not restricted by traditional modular build constraints
- No limitations on ceiling height, wall-to-wall spans, or internal geometry
Off-Site Educational Consulting
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.
FDA Compounding 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
USP Compliance & Consulting
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.
GMP / FDA Compliant Systems & Components
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.
Services & Solutions Overview
Terra deploys architects, engineers, and subject-matter experts to ensure the alignment of aesthetic appeal, facility integration, and floor planning with respect to multi-functional spaces.
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
HVAC Engineering & Components
Terra orchestrates full-service cleanroom solutions, including their associated air handling and filtration systems. Terra's customers benefit from substantial improvements in design methodologies, which stem from insights gleaned in high-performance ISO 5 — ISO 7 cleanroom builds for pharmaceutical, semiconductor, and biotech industries.
Architecture & Lab Planning
Terra offers full service packages for the design of large-scale facilities featuring multiple suites, offices, gowning rooms, mezzanines, and cleanroom spaces. For labs and cleanrooms, we provide comprehensive end-to-end outfitting solutions, including full furniture installations and meticulous planning of process flows that optimize the movement of people and products between clean and dirty zones.
Commissioning & Validation
Terra's cleanroom testing and certification services are designed to ensure the optimal performance of cleanroom filtration systems, clean air benches, laminar flow hoods, and other airflow-reliant systems. Our comprehensive certifications include airborne particle counts to assess the cleanliness level, HEPA filter velocity, and leak scans to ensure filter integrity, along with temperature and humidity checks for environmental stability.
Get a Cleanroom Consultation
Terra offers fully integrated cleanroom engineering design, architecture, construction, and system integration. Rest assured, you'll have a single point of contact for delivering a complete solution.
Ask a Terra Cleanroom Specialist
Cleanroom Design & Engineering
Building commissioning is an essential process to ensure that all systems within a building, including mechanical (HVAC and refrigeration), electrical, lighting, life safety, plumbing, and specialized equipment like laboratory apparatus, perform optimally and according to specifications. This process verifies that the chosen products and systems meet the manufacturer's claims and are suitable for the intended project.
Get a Cleanroom Consultation
Terra offers fully integrated cleanroom engineering design, architecture, construction, and system integration. Rest assured, you'll have a single point of contact for delivering a complete solution.
Ask a Terra Cleanroom Specialist
Contact Terra Universal
Combining high-throughput, automated fabrication equipment with a robust, active stock of raw materials, Terra is capable of producing cleanrooms of any design, size, scope, and complexity at industry-leading build times.
Global Vendor Network
Terra's network offers over 20 global sales regions and 80 major suppliers with a wide range of global shipping options, Get door-to-door international delivery for brands such as Labconco, Thermo Fisher, Metro, Eagle, Biofit, and Germfree