Regulatory Strategy And Submission
Advancing regulated products across global markets requires a CRDO with integrated CMC depth, QbD discipline, BE/PK expertise, and broad-spectrum regulatory intelligence. Healios Labs embeds TPP/QTPP-to-CQA mapping, design-space justification, and risk-based development logic into every complex generic, 505(b)(2), biosimilar, and NME program. Our framework integrates ICH Q8–Q12, ICH M4Q structuring, PBPK–BE correlations, impurity-qualification methodology, stability trending algorithms, and phase-appropriate validation to ensure alignment across eCTD Modules 2, 3, and 5. Using Dossier Architecture Thinking, structured guideline interpretation, global regulatory-landscape analytics, and lifecycle-ready documentation within Pinnacle-class regulatory platforms, Healios anticipates FDA, EMA, PMDA, MHRA, and TGA expectations to reduce post-submission variability.
Healios provides end-to-end regulatory support spanning development strategy, CMC dossier authoring, clinical/nonclinical summarization, labeling, submissions, and lifecycle management. Our teams prepare scientific-justification packages, literature-based rationales, analytical-method lifecycle files, nitrosamine and E&L assessments, specification-setting logic, and statistical justification frameworks. We conduct query-readiness conditioning, RFI simulations, deficiency-response mapping, and Pre-IND/Scientific-Advice briefing preparation with structured correspondence tools. Our validated publishing workflows utilize Pinnacle-style XML/eCTD compilers, automated granularity mapping, hyperlink governance engines, metadata validation, and compliant transmissions through FDA ESG, EMA IRIS, and other national gateways. This integrated regulatory model strengthens dossier defensibility, accelerates multi-market approvals, and minimizes sponsor burden.
This approach supports our complete portfolio of regulatory and CMC solutions.
