Who We Are

TBD Pharmatech is a dual-site, EU-GMP-certified Contract Development and Manufacturing Organization (CDMO) headquartered in Tartu, Estonia. We specialize in small-molecule API development and niche-to-mid-volume commercial manufacturing, providing integrated support from early route design through validated EU-based supply.

Our Expertise

Full EU-GMP CDMO services and manufacturing built for niche-to-mid-volume APIs.

  • End-to-End CDMO Services: Complete small-molecule API technology development or technology transfer
  • Manufacturing: Clinical and commercial batch production under cGMP standards
  • Analytical & Regulatory Services: Comprehensive analytical method development and full regulatory support
  • Distribution & Sourcing: Reliable API distribution and global sourcing solutions under Good Distribution Practice (GDP)

We currently operate two GMP certified facilities (Tiigi and Välja sites) in Tartu, Estonia.

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FACILITIES

DOSSIERS

STAFF

PRODUCTION ROOMS

Why Partner with TBD Pharmatech?

Our international team of creative scientists and problem-solvers provides customized solutions to your fine chemical project needs. We guide you through the complexities of substance development: from route scouting to GMP compliant commercial supply, and regulatory compliance.  Expect lasting partnerships built on client satisfaction.

EU-GMP Manufacturing for Niche and Mid-Volume APIs

We are a dual-site, EU-GMP-certified CDMO purpose-built for small-molecule APIs that require technical depth and reliable supply. Our platform is optimized for niche-to-mid-volume production, typically from multi-kilogram campaigns up to tonne-scale annual demand. No high-volume commodity models.

Full Regulatory & Quality Infrastructure

Operating under EU GMP (since 2008), ISO 9001, and GDP licences, we integrate analytical QC, Qualified Person release, and CMC regulatory support directly into our manufacturing workflow. This ensures compliant, traceable supply from development through distribution.

Integrated Development-to-Commercial Pathway

From early route design and process optimisation at our Tiigi site to validated commercial manufacturing at our Välja facility, we offer a seamless scale-up pathway under one unified quality system. No fragmented handovers, just structured tech transfer and predictable progression.

EU-Based Supply Security

With two fully GMP-certified facilities in Estonia, we provide stable, EU-based API manufacturing backed by controlled material flows, validated processes, and transparent oversight supporting both clinical programs and long-term commercial needs.

Certifications

Quality Certifications and Compliance

Our quality and service reliability rest on a unified system that spans development, manufacturing, and logistics. TBD Pharmatech has operated under EU GMP since 2008, holds ISO 9001:2015 certification for its Quality Management System, and now also maintains a Good Distribution Practice (GDP) licence for sourcing, warehousing, and outbound shipments. Together, these accreditations keep every stage production, testing, and distribution in full alignment with global regulatory expectations, ensuring consistent, traceable quality for your drug-substance projects.

GMP Certified
Tiefenbacher
Galmed Pharmaceuticals
Cfm
Double Bound Pharmaceutical
Alfasan International