Ensure reliable results

Validation

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In a production plant, you need to know that your products are produced with the same processes, whether in China or Spain. You must meet ever-changing regulatory requirements and good practices so that you are audit-ready.

What we do

  • 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
  • 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
  • Continuous training plan
  • On-site training on demand
  • Basic and advanced GMP/GDP training

GxP, Quality and Regulatory Consulting

Validation of processes and systems

The Trescal Advantage

To ensure that life science products are fit for intended use, we document that the manufacturing process can repeatedly produce the intended result. We provide:

Validation of systems,

processes, analytical methods, tests, facilities, utilities and equipment

Accreditations and Standards

Client results

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

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