Meet standards, GxP guidelines and regulatory compliance to be audit-ready

Life Sciences

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What we doAccreditationsClient resultsrelated services

In the life sciences industry, you hold the health and wellness of people in your hands. Rapidly evolving regulatory forces and consumer expectations require exacting processes at lower costs. You need to trust that all of your GxP systems, processes, software, equipment and facilities meet quality requirements so that you can focus on your core business. Trescal provides documented evidence that you meet internal standards, GxP guidelines and regulatory compliance. Our single source solution for life sciences provides precision expertise in every service, geography and instrument across the world.

What we do

  • Computer system validation
  • Computerized systems
  • IT infrastructure
  • Facilities & utilities (e.g. HVAC, water for pharmaceutical use, gas systems, sanitation, drainage systems, plumbing)
  • Cold chain management
  • Transport
  • Cleaning process management
  • Production and packaging processes
  • Analytical methods
  • Development and optimization of GxP quality systems
  • Manufacturing process & facility transfers
  • Pharmacovigilance quality system
  • Quality risk management
  • Data integrity and governance
  • Audits (internal, supplier)
  • Regulatory documentation
  • Serialization / traceability
  • Transition CSV to CSA (FDA)
  • CPV and PQR reporting
  • Computerized systems and electronic data in clinical trials
  • Medical devices & software
  • Training services
  • Equipment: autoclaves, incubators, refrigerators, freezers, water baths, ovens, etc.
  • Installations: clean rooms, thermal control storage, sterilization and depyrogenation, production, conditioning and analysis equipment
  • Pharmaceutical services: air conditioning; water, steam and gases; computer systems for document management, process and facility conditions
  • Process and laboratory instrumentation
  • Multiple variables
  • Tablet quality control equipment
  • Calibration services on-site or in-house via pick-up and delivery service
  • Optimization of your calibration plan
  • Maintenance and repair

Validation of processes and systems

GxP, quality and regulatory consulting

Qualification of equipment and installations

Calibration of measuring instruments

Accreditations and Standards

Client results

8 of top 10 pharmaceutical clients served
30 years experience in life science validation and qualification
600 GxP, FDA, ISO/IEC Pharmacopeia trained experts

Case Study

Life Science brochure

Get a quick overview of our complete service offer for life science clients, whether you're in R&D, manufacturing, distribution or dispensing.

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Managing calibration and logistics of pharmaceutical assets

The client needed to combine calibration and logistics services to reduce delay. They also needed to manage the pool of 300 service kits used by 400 engineers.

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related services

Validation

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Qualification

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Calibration

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