Pharma & Biotech Services
Comprehensive R&D Support for Drug Development
Biotts provides pharmaceutical and biotechnology companies with formulation development, analytical support, and laboratory services designed to generate decision-ready data at each stage of development. Operating from a GMP-certified R&D facility in Poland, we function as an extended R&D team using structured workflows, validated methods, and documentation suitable to support regulated development.
Our services span early drug development, formulation across multiple dosage forms, analytical and CMC capabilities, release and permeation performance testing, stability programs, and CDMO-related support. Projects are structured with defined objectives and acceptance criteria upfront, executed to generate interpretable results, and delivered with reporting that supports partner decision-making and regulatory submissions.
Service Categories
Early Drug Development
ADME/DMPK profiling, medicinal & synthetic chemistry support, in vitro/in vivo pharmacology, and toxicology studies to inform candidate selection and preclinical planning.
Pharmaceutical Formulation
Formulation across oral solids, semi-solids, and transdermal systems, including prototype development, custom dosage form design, and scale-up readiness with GMP documentation.
Bioanalysis & Analytical CMC
Analytical method development/validation, bioanalysis of biologics/biosimilars, impurity profiling, and instrumental analysis supporting CMC packages and regulated requirements.
Drug Release & Permeation
Dissolution/release profiling, IVPT, and in vitro-in vivo relationship assessments where applicable.
Stability & Microbiology
Long-term and accelerated stability under GMP conditions plus microbiological testing with compliant documentation.
CDMO, Advanced Therapies & Regulatory
GMP documentation preparation, CMC coordination, regulatory support, and manufacturing pathways for clinical programs (scope defined per program).