Pharmaceutical Formulation

From Compound to Dosage Form

Formulation development turns an active pharmaceutical ingredient into a stable, manufacturable dosage form with the intended release and performance profile. It defines critical quality attributes and manufacturability to support CMC decisions and regulatory planning.

Biotts supports pharmaceutical and biotech partners with formulation development across oral solids, semi-solids, and transdermal systems, backed by a GMP-certified R&D facility and integrated analytical support. We work from early feasibility through scale-up readiness, producing documentation that can be structured to support CTD/CMC requirements (e.g., Pharmaceutical Development sections) and tech transfer activities.

Our workflow is stage-gated: feasibility screening identifies viable approaches, optimization refines formulation and process parameters, and scale-up readiness work defines practical manufacturing conditions. Quality-by-design (QbD) principles guide development – including Quality Target Product Profile (QTPP) definition, critical quality attribute (CQA) identification, risk assessment, and design of experiments (DoE) where appropriate – with stability and performance characterization applied to support change control and regulatory expectations.