CDMO, Advanced Therapies & Regulatory
From Development to Clinical and Commercial Readiness
Progressing from laboratory development to clinical programs and commercial manufacturing requires GMP-compliant production capabilities, regulatory documentation, and project coordination aligned with submission requirements. Whether supporting clinical trial materials, advanced therapy development, or regulatory package preparation, these activities bridge R&D and manufacturing while addressing regulatory expectations.
Biotts provides CDMO services, advanced therapy development capabilities, regulatory affairs support, and clinical data analysis from our GMP-certified facility in Poland. We support pharmaceutical and biotech partners in navigating the transition from development through clinical supply and commercial readiness, with services tailored to program stage and regulatory pathway.
Our capabilities span five interconnected areas: contract development and manufacturing for conventional dosage forms, specialized cell and gene therapy manufacturing including decentralized CAR-T approaches, regulatory documentation and GMP compliance support, CMC project coordination across development stages, and clinical data analysis including PK/PD modeling supporting regulatory submissions.
Programs generate GMP-compliant batches, technology transfer packages, regulatory submission-ready documentation, CMC coordination reports, and clinical data analysis packages supporting clinical trial authorizations, marketing applications, or manufacturing transitions depending on program needs and regulatory pathway.
Explore detailed capabilities for each service area below, or contact Biotts to discuss CDMO, advanced therapy, regulatory, or clinical data analysis requirements for your program.