Regulatory Affairs Advisory
ValiCore ADVISORS helps pharmaceutical companies and Marketing Authorisation Holders move faster to market with senior regulatory advisory across the whole procedure: a preliminary assessment and regulatory strategy that shows where your dossier stands, CTD authoring and management of Modules 1 to 3 with an assessor's eye and procedural support through the authority's questions to approval. Our model is built for flexibility: direct partnerships with manufacturers and MAHs, and white-label collaboration with consulting firms seeking specialised regulatory depth.
Marketing authorisation in Europe - from dossier to approval
ValiCore ADVISORS works alongside your quality and regulatory functions and authors or reviews the target modules. Whether you are building a CTD dossier or adapting your portfolio to the revised EU pharmaceutical legislation, our assessors read it the way the agency will — so that the questions that come back are fewer, and none of them avoidable. After submission we stay with you through the procedure and the agency's questions.
What we do
Whether you are entering a new market for the first time or managing a complex portfolio, ValiCore ADVISORS provides structured, GMP-aligned regulatory support at every stage. Three foundational service areas covering regulatory strategy, CTD authoring, and assessment support — all updated for the evolving M4Q(R2) landscape and the new digital submission requirements.
Preliminary Assessment & Regulatory Strategy
Before investing in a full dossier build, know exactly where you stand. Our preliminary assessment is a structured review of your marketing authorisation dossier with assessment-grade expertise — identifying gaps and providing a clear roadmap to improve submission quality and ensure regulatory requirements are met for faster approval.
- Structured dossier gap analysis vs. EMA & ICH requirements
- Regulatory pathway selection (MRP, DCP, NP)
- Submission quality improvement roadmap
- Risk-ranked remediation plan with owner & deadline matrix
- List of Questions with pre-drafted guidance
CTD Dossier Creation & Management
We take full ownership of your CTD dossier — authoring, compiling,
cross-referencing, and quality-reviewing every module with the same lens an authority assessor would apply. For M4Q(R2)-era submissions, we use standardised DMCS-aligned templates for Module 3 with embedded cross-references to Module 2 justifications.
- Module 2 expert report and overview
- provides regulatory-grade review of Module 3 - Quality with line-by-line expert assessment, identifying gaps
- QA review prior to submission
- informed choice and guidance regarding buying a dossier
- Full support in authoring the dossier
- DMCS-structured Module 3 templates cross-referenced to Module 2
- eCTD formatting
Procedural Support
We provide end-to-end support throughout the marketing authorisation procedure, helping you prepare clear, scientifically, and fully documented responses to questions raised during the assessment.
- Scientific and regulatory review of authority questions and identification of the required supporting data
- Cross-functional assessment of the impact of responses on the dossier and product information
- Preparation of written explanations, scientific justifications, and revised dossier sections
- Review of updated SmPC, PL, labelling, and other documents submitted during the procedure
- Final consistency, completeness, and submission-readiness review before transmission to the authority
How we work
- from first contact to approved dossier -
A structured, milestone-driven engagement model — so you always know where the project stands and what comes next.
1
Discovery & Scoping
A first confidential call to understand your product, target markets, current documentation status, and timeline. We map your situation against regulatory requirements and identify the right entry point — pre-assessment and full dossier.
Output: Scope of work proposal with fixed or capped fee structure and timeline
2
Pre-assessment & Gap Report
Structured review of your existing documentation, analytical data, manufacturing process, and GMP compliance status. We produce a risk-stratified gap report with clear findings, regulatory citations, and a prioritised action plan — no ambiguity.
Output: Gap Analysis Report + Regulatory Pathway Recommendations
3
Dossier Authoring
Working closely with your CMC, QA, and RA teams, ValiCore ADVISORS authors or reviews the target modules. We maintain version control, track open items, and coordinate with your site SMEs to fill data gaps — keeping the submission on schedule.
Output: Draft and final Module 1, 2, 3 documents, ready for eCTD compilation
4
Quality Review & Submission Support
Pre-submission QC review of the complete dossier for internal consistency, cross-module alignment, and compliance with the target authority's procedural requirements. We support the submission process and remain engaged through the assessment phase.
Output: Submission-ready dossier + agency response strategy
5
Deficiency Response & Approval
When due-date lists of outstanding issues arrive, we support you with evidence-based responses and guidance to address each question comprehensively. Our experience with assessor expectations means fewer follow-up rounds and faster resolution.
Output: Deficiency response package + updated dossier sections
REGULATORY FRAMEWORK
The guidelines
we work to
EudraLex Volume 2
Pharmaceutical legislation for medicinal products for human use - the primary legal framework for EU market authorisation
ICH CTD (M4)
Common Technical Document structure and content requirements - the international harmonised submission format
ICH Q8 / Q9 / Q10
Pharmaceutical development, risk management, and pharmaceutical qualitysystem - the quality trilogy underpinningModule 3
EudraLex Volume 4
GMP guidelines for human and veterinary medicinal products - directly relevant to Module 3 manufacturing and quality sections
QRD Templates
Quality Review of Documents templates for SmPC, labelling, and patient information leaflet - mandatory for Module 1 product information
CHMP Guidelines
Committee for Medicinal Products for Human Use - product-class specific guidelines (stability, impurities, bioequivalence, etc.)
Explore a strategic partnership
Partner with ValiCore ADVISORS to move faster, reduce regulatory risk, and build a dossier strategy built to last through the upcoming EU legislative changes.
