Our Commitment to Quality

At the core of our pharmaceutical manufacturing is a robust quality system built for global compliance and client trust. Our team of experienced quality professionals ensures manufacturing in accordance with current Good Manufacturing Practice (cGMP) and ISO 9001 standards.

GMP-Qualified Facilities

Our Tiigi facility in Tartu Biotechnology Park serves as the operational nucleus, hosting:

  • R&D and Quality Control laboratories
  • Corporate headquarters and admin center
  • Six GMP-qualified production rooms (mg to 150 L scale)
  • 1000 m² of lab and production space
  • Stage-specific specs and quality

Our new Välja facility will expand our GMP capacity with: 

  • Up tp 13 production rooms (50–1000 L reactors)
  • Over 3000 m² of production space
  • Flexible, scalable production for small molecules

Full Lifecycle Quality Oversight

ASMF, DMFs, CEPs as per customer need 

  • Stage-specific specs and quality checkpoints
  • Qualified suppliers and regular audits
  • Fast, structured complaint resolution
  • Documented and traceable quality systems and processes
  • Proactive registration support aligned with target markets
  • Lifecycle management of regulatory documentation
  • Integrated oversight across analytical, process, and release quality controls
drug development

ISO 9001 Certified

Our ISO 9001:2015-certified Quality Management System is integral to TBD Pharmatech’s daily operations, guiding work from early R&D through GMP batch release. Every workflow is formally mapped, routinely measured, and subject to scheduled reviews so that process performance and compliance remain transparent and traceable.

A dedicated Quality Assurance team carries out rolling internal audits, management reviews, and real-time deviation tracking to maintain constant inspection readiness. Structured change-control and CAPA programmes capture lessons learned and translate them into documented process improvements, while supplier qualifications, audits and client feedback provide the data needed for ongoing system updates.

These measures deliver predictable lead times, accurate documentation, and consistent product quality across both the Tiigi and Välja sites, supporting reliable project planning and regulatory compliance.