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
GxP, Quality and Regulatory Consulting
- 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
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:
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