Regulatory application studies for EMEA, FDA and MHRA

Pharmidex provides comprehensive regulatory-aligned preclinical support spanning GLP toxicology, GLP bioanalysis and GCP-compliant clinical sample analysis, enabling the generation of data suitable for regulatory submissions and clinical development decisions. Our integrated approach supports SMEs and biopharma clients in preparing robust IND/CTA packages, reducing development risk and ensuring alignment with global expectations. Our GLP toxicology services include single- and repeat-dose studies, toxicokinetic (TK) assessments, dose formulation analysis, sample collection and archiving, with study designs tailored to regulatory objectives. We operate GLP-accredited facilities, maintain validated equipment and conduct work in accordance with OECD principles, MHRA surveillance expectations and relevant species-specific guidelines. Where required, we coordinate second species and specialty studies through qualified partner facilities to ensure coherent regulatory packages. Our GLP bioanalysis offering covers method development, partial and full validation (per relevant FDA/EMA guidance), TK bioanalysis, metabolite profiling, stability studies, and quantitative LC-MS/MS or ligand-binding assay support for small molecules, peptides, biologics, ADCs and advanced modalities. Data integrity, chain of custody, and audit trails are embedded throughout all stages of analysis. Pharmidex also supports GCP-compliant clinical sample analysis, including bridging of validated methods from preclinical to clinical settings, quantitative assays for Phase I/II samples, and secure sample handling, reporting and data transfer aligned to sponsor and CRO requirements. Our regulatory strength lies in scientific depth, operational transparency and integration across toxicology, DMPK and bioanalysis. We provide clear documentation, QA oversight, study reports and regulatory-ready data formatted for global submissions, enabling faster progression of novel therapeutics into the clinic.