Terra Consulting & Expertise

Complying with state and federal regulations is complicated, especially when holding multiple state licenses. Terra partners with several specialized firms in the pharmaceutical and healthcare sector to provide clinical, programmatic, and regulatory expertise. We help our clients navigate challenges and obstacles to growth, both nationally and abroad, positioning them for long-term compliance.

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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. 

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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.

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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.

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Laboratory Qualification

On-site compliance assessments involve a thorough lab evaluation, including staff competency, policy and procedure reviews, testing and documentation requirements, quality assurance, and storage and handling practices.

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Healthcare Consulting

Terra streamlines healthcare facility planning with partner services for efficiency benchmarking, space utilization studies (understanding user needs), code compliance assessments, and layout optimization

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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 collaborates with several established 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 dedicated partners embody 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

Complying with state regulations can be complicated, especially with multiple state licenses. Therefore, Terra partners with several pharmaceutical and healthcare consulting firms that provide extensive clinical, programmatic, and regulatory knowledge within pharmaceutical and healthcare organizations, both nationally and abroad. Together, we help our clients confront and overcome challenges and obstacles to growth, positioning them for long-term regulatory and business success.

Alongside our trusted partners, 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 
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Off-Site Educational Consulting

Terra's USP Pharma service extends to off-site educational consulting, aimed at enhancing understanding of compliance importance, offering best practice guidance, and support for pharmaceutical compounding spaces. This includes reviewing current and proposed renderings, constructing preliminary design drafts, providing equipment recommendations, and advising on air filtration systems and HVAC specifications to ensure optimal functionality 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

With the support of Terra's USP specialized partners, services extend to off-site educational consulting, aimed at enhancing understanding of compliance importance, offering best practice guidance, and support for pharmaceutical compounding spaces. This includes reviewing current and proposed renderings, constructing preliminary design drafts, providing equipment recommendations, and advising on air filtration systems and HVAC specifications to ensure optimal functionality and compliance.

Terra Universal specializes in USP Pharmacopeial Compliance and Consulting, providing both on-site and off-site support to ensure laboratories meet USP standards <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.

Trusted Service Providers

Terra's network includes architectural designers and specialty application consultants to ensure alignment of aesthetic appeal, facility integration, and floor planning with respect to multi-functional spaces.

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Cleanrooms & Solutions

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BioSafe® Modular Cleanrooms

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

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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.

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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.

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Modular Hardwall

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

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Traditional Stick-Built

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

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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 collaborates with several partners to orchestrate full-service cleanroom solutions and their associated air handling 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. 

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Architecture & Lab Planning

For cGMP-compliant drug discovery and USP <797> drug compounding operations, stick-built designs are a common choice, given the ease of installing coved flooring, spray-down resistant wall and ceiling panels, and the ability to hide plumbing lines and electrical cords. However, drywall is prone to mold and mildew growth in moist conditions, and applications requiring humid environments, like vivariums, animal husbandry, and cell culture research, choose modular systems.

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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. 

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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.

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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.

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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

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