Regulatory Affairs & eCTD Submission Services
Regulatory Affairs & eCTD Submission Services
Expert guidance. Tailored strategies. Seamless regulatory navigation.
BioEthica provides clients with the insight and strategy needed to streamline complex regulatory processes for pharmaceuticals, biologics, and combination products. Our consultants bring extensive experience from both FDA and EMA regulatory environments, helping clients confidently move from development to approval and beyond.
We offer strategic, hands-on regulatory support – whether you’re preparing for your first IND or submitting a global MA in Common Technical Document (CTD/eCTD) format.
Global Regulatory Submission Support
We manage all aspects of your regulatory submissions to ICH-member health authorities including FDA, EMA, MHRA, Health Canada, and PMDA:
Full eCTD Lifecycle Management
Complete support from Module 1 to 5 - authoring, compiling, reviewing, and submitting.
Expert Regulatory Document Authoring
Clinical, nonclinical, and CMC sections - authored by experts who understand both scientific rigor and regulatory expectations.
Data Quality Control (QC) and Submission Validation
We perform detailed QC and use validated tools to ensure submission packages are accurate, consistent, and inspection-ready.
Hyperlinking, Bookmarking, and Document Formatting
Present your data professionally with fully navigable, well-organized documents compliant with FDA and EMA standards.
XML Backbone and Submission Publishing
Our team handles the creation of XML backbone files and performs successful submissions through ESG, CESP, and other portals.
Up-to-Date Templates
We use current, region-specific eCTD templates to ensure each submission meets regulatory authority expectations.
Strategic Regulatory Guidance for US & RoW Markets
We help you navigate the patchwork of global regulatory frameworks with compliant, risk-balanced strategies:
- Regulatory Pathway Analysis & Submission Planning
- ICH & WHO Guidelines for Stability, Water Quality, and Climatic Zones
- Post-Approval Change Strategies for US and EU
- FDA FD&C Act Law & Evidence Compliance (21 CFR and 45 CFR)
- Expertise Across GxPs and Regulated Systems (GLP, GMP, GCP)
- CMC Section Reviews and Process Validation Strategy (Biologic & Small Molecule)
- Labeling & Package Insert Compliance Strategy
- Nonclinical Data Evaluation for Global Submission Alignment
Why Choose BioEthica?
With a team of former FDA professionals and seasoned global regulatory experts, BioEthica offers:
Deep Knowledge of US FDA and EU EMA Expectations
Leverage insider understanding of regulatory frameworks across both US and European markets - ensuring global alignment and compliance.
Proactive Approach to Anticipate Regulator Concerns
Stay ahead of evolving requirements with strategies that foresee and address potential regulatory challenges before they arise.
Templates, Tools, and Techniques from Real Inspections
Apply proven methods and resources shaped by first-hand inspection experience, ensuring readiness and consistency.
Proven Track Record of Successful Submissions
Benefit from a history of seamless regulatory submissions that navigate complex processes efficiently and effectively.
BioEthica translates FDA expectations into actionable strategies for EMA-regulated firms enabling them to expand globally with confidence.
with clarity, precision, and compliance?