TBD Pharmatech

Who We Are

TBD Pharmatech is a small-molecule API CDMO with EU cGMP manufacturing facilities in Tartu, Estonia. We provide contract development and manufacturing services for pharmaceutical and biotech companies, covering route scouting, process development, scale-up, and GMP manufacturing. Our focus is on niche-to-mid-volume APIs (batches sizes 3–200 kg), supporting projects from early route design through validated EU-based supply. We operate two EU cGMP-certified manufacturing sites (Tiigi and Välja) and provide integrated development, analytical, and regulatory support.

Our Expertise

Small-molecule API CDMO services in the EU, covering process development, scale-up, and GMP manufacturing for niche-to-mid-volume APIs.

End-to-end CDMO services for small-molecule APIs, including route scouting, process development, and technology transfer
GMP manufacturing for clinical and commercial API production
Analytical method development, validation, and regulatory support (ASMF, DMF, CMC)
Technology transfer from development to GMP manufacturing
Quality-controlled distribution and sourcing of chemicals

We operate two EU cGMP-certified manufacturing facilities in Tartu, Estonia (Tiigi and Välja sites).

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) and ISO 9001; 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. Together, these accreditations keep every stage of production and testing in full alignment with global regulatory expectations, ensuring consistent, traceable quality for your drug-substance projects.

We are very privileged to work with TBD Pharmatech on a long-term basis on many different projects

Cfm Oskar Tropitzsch GmbH
TBD is one of our strategic partners and work closely with us to fulfil our needs and requirements in a variety of ways. Their sense of collaboration and flexibility with their customers help us feel convenient while working on a tight deadline.

Double Bond Pharmaceutical
TBD offers a unique level of expertise in API synthesis combined with flexibility, open communication as well as speed in all activities.

Tiefenbacher Group
We appreciated the professionalism of the TBD team, and were very satisfied with their customer service and quality of the ASMF for their API’s.

Alfasan International B.V.