Services
High-Quality Regulatory Submissions for regulatory success
Preparation of immunogenicity (IRA and ISI) and CMC (eCTD Module 3) documentation to support regulatory meetings, clinical trial applications (CTA), Investigational New Drug (IND), Biologics Licence Application (BLA, sBLA), New Drug Applications (NDA, ANDA) and Market Authorization Application (MAA) aligned with ICH regions reglamentations (EMA, FDA).
A well-structured narrative increases clarity, reduces regulatory questions, minimizes review cycles, and supports fast and efficient approvals.
Regulatory strategy
We design regulatory strategies that position your data effectively for agency review, define clear objectives for regulatory interactions, and anticipate potential areas of concern before submission. Particular attention is given to the integration of immunogenicity and CMC considerations within the broader clinical development narrative.
Formal meetings
Preparation and support for formal regulatory interactions, including INTERACT, pre-IND and Type C/D meetings, Scientific Advice and Advisory Committee meetings, helping define strategic questions, company positions, and supporting evidence.
Module 2&5 - Immunogenicity
Preparation of Immunogenicity Risk Assessments (IRA) and Integrated Summary of Immunogenicity (ISI) for MAA/BLA/NDA/ANDA submissions, ensuring alignment between risk assessment, bioanalytical strategy, and clinical outcomes.
We support preparation of “in silico” and “in vitro” bioanalytical reports to support regulatory meetings and filings.
Module 3
Gap analysis of analytical comparability protocols and results to ensure scientific consistency, regulatory alignment with ICH Q6B, and preparedness for health authority queries for IND, EOP2, BLA, and post-approval manufacturing changes, with particular emphasis on the relevance of CQA changes to drug disposition and safety