Formulation Development

Licenses and Supply-chain management, Pre-formulation studies, Intellectual Property Evaluation, Innovator characterization, Analytical method development, Product development, QbD development

Scale up & TT

Process Optimization, Analytical methods validation, Process Validation

BE/Clinical

Clinical development planning, CRO/Central lab/Statistic/CDM identification and oversight, Full study documentation preparation & management, Independent study monitoring & audits, Medical writing, Biowaivers, medical rationales & scientific justifications, GCP audit

Regulatory Strategy & Compliance

Scientific Advice, Registration & Marketing Strategy, GCP audit, GMP audit, QP service

Dossier Compilation

Data gap analysis & revision, Dossier draft per country-specific guidelines, Global CTD/eCTD conversions, CMC writing, Quality expert reports, Global Translation

Registration

Agency deficiency management, Structured product labelling publishing

Pharmacovigilance

Case processing, Causality assessment & Signal detection, Literature screening, QPPV & Local safety contract services, PSMF, xEVMPD/xEVPRM, Reporting ICSRs, PSURs/PADERs, PMS, Audits

Life Cycle Management

Renewals & Variations application, Dossier updating and consolidation, eCTD life cycle maintenance