Ensure reliable results


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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:

GxP, quality and regulatory consulting services

in line with 21 CFR Part 11, annex 11 EU GMP, Data Integrity, GAMP5 and GAMP RDI

Validation of systems

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

GAMP5 and ISPE approaches

in executing automated and equipment validation projects

Process-oriented methodology

consistent with GAMP and ISPE procedures and templates to control costs

Practical solutions

based on ASTM E2500-07 and ISPE guidelines that provide quality and ensure a more cost-controlled, efficient project


with ICH Q8, ICH Q9, and ICH Q10 documents

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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