How do you build a viable regulatory affairs strategy for your products across Pharma, Biotech, MedTech and IVD?
We develop product-specific Regulatory Affairs roadmaps across all domains: classification, authority strategy, dossier (CTD/eCTD or technical documentation) and lifecycle management with variations and renewals. Where classification, regulatory route and evidence requirement are not fixed before writing, documents arise that get reopened during the procedure.
Overview
Which regulatory hurdles stand in the way of market access?
Pharma, Biotech, MedTech & IVD · AMG, EMA procedures, MDR (EU 2017/745), IVDR (EU 2017/746), CTD/eCTD
Last updated: June 12, 2026
Regulatory affairs brings together technical, clinical and legal requirements across the entire product lifecycle.
- Divergent requirements from multiple authorities: the EMA via the centralized procedure under Regulation (EC) No 726/2004, the FDA, the PMDA and national authorities each call for their own dossier structure and evidence.
- Parallel compliance management across product classes: medicinal products under the AMG and Directive 2001/83/EC, medical devices under the MDR (EU 2017/745) and in vitro diagnostics under the IVDR (EU 2017/746) follow different logics.
- The dossier is only as good as its structure: the Common Technical Document under ICH M4 requires a coherent link between quality, non-clinical and clinical data; gaps in Module 3 trigger questions about Module 5.
- Post-authorization changes tie up resources: variations under Regulation (EC) No 1234/2008, renewals and line extensions must be classified and submitted on time, otherwise they jeopardize the authorization status.
- Staffing shortages in RA departments delay procedures; with parallel submissions across several markets in particular, there is often a lack of capacity for sound authority communication.
Services
How we support you
Regulatory Strategy & Regulatory Roadmap
Product-specific roadmap with a defined regulatory pathway (EMA centralized under Regulation (EC) No 726/2004, national, or notified body under MDR/IVDR), classification and evidence plan, as a documented basis for decision-making before project start.
Submission Management
Coordination of submissions to the EMA, national authorities and notified bodies, including responses to deficiency letters; the outcome is a traceable submission and response history.
How we work together
What it comes down to
In regulatory affairs, more is decided than written.
Three decisions have to be in place before the first page is written: the regulatory pathway (centralized via the EMA under Regulation (EC) No 726/2004, national under the AMG, or via a notified body under the MDR (EU 2017/745) and IVDR (EU 2017/746)), the classification of the product, and the evidence requirements that the chosen authority expects.
If you define these three before the dossier under ICH M4 or the technical documentation is created, you build modules that survive the procedure. Leave them open, and the modules have to be reopened after the first round of authority feedback.
Concurrency weighs heavier still. Multiple markets, multiple authorities and an ongoing lifecycle management with variations under Regulation (EC) No 1234/2008 must be served from a single coordinated core dossier, otherwise the versions diverge and every subsequent change is maintained multiple times.
That is why strategy and roadmap come first for us, authority engagement through scientific advice comes before submission, and the dossier is structured so that maintaining it across the lifecycle costs little rather than a great deal during the procedure.
Our approach
Our approach
Step
Result
Assessment & Classification
Confirmed product category and applicable legal framework (AMG/EMA or MDR Annex VIII / IVDR), documented as the starting position.
Strategy & Roadmap
Defined regulatory pathway, timeline and submission plan, identified evidence needs.
Early Authority Engagement
Completed scientific advice or pre-submission meeting with documented feedback on the strategy.
Dossier Build
Complete CTD/eCTD under ICH M4 or technical documentation, consistent across modules.
Submission & Authority Questions
Submitted application, structured processing of deficiency letters through to authorization.
Lifecycle Maintenance
Established variations and renewal process that continuously safeguards the authorization status.
Common pitfalls
Where projects commonly fail
The dossier is written before the strategy.
Without a defined regulatory pathway and confirmed classification, modules are created that have to be reopened after the first round of authority feedback, the most expensive correction loop in the entire procedure.
Scientific advice is skipped or used too late.
Documented authority feedback from a pre-submission meeting reduces the risk of deficiency letters; submitting without this alignment means learning of fundamental objections once the procedure is already under way.
Variations are classified incorrectly.
A change rated as minor (Type IA) that is in fact a major change (Type II) under Regulation (EC) No 1234/2008 leads to objections and can jeopardize the authorization status rather than maintaining it.
Medicinal product and medical device logic are mixed up.
The AMG/EMA world with the CTD under ICH M4 follows different processes than the MDR/IVDR world with technical documentation and a notified body; transferring requirements across the two builds formally incorrect dossiers.
Parallel submissions across several markets run without a coordinated core dossier.
When each authority is served from separate sources, the versions diverge and subsequent changes must be maintained multiple times, an avoidable overhead across the lifecycle.
Regulatory Affairs
Do any of these pitfalls apply to you?
In a first call we assess your situation and say what needs clarifying first in your case. Without obligation, reply usually within one working day.
FAQ
Frequently asked questions
Sources
- Regulation (EU) 2017/745 (MDR) - primary text, Art. 61, Annex VIII
- Regulation (EU) 2017/746 (IVDR) - primary text
- Regulation (EC) No 726/2004 - centralized EMA marketing authorisation procedure
- Directive 2001/83/EC - Community code for medicinal products for human use
- Regulation (EC) No 1234/2008 - examination of variations
- Arzneimittelgesetz (AMG) (German Medicinal Products Act) and AMWHV
- ICH M4 - Common Technical Document (CTD/eCTD)
- Writer source: regulatory-affairs.md (Entourage Website Writer)
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Case Studies
What this looks like in practice
Related insights
All insights →Regulations & standards considered
- EU 2017/745 (MDR)
- MDR Annex VIII (classification rules)
- MDR Art. 61 (clinical evaluation)
- EU 2017/746 (IVDR)
- Regulation (EC) No 726/2004 (centralized EMA marketing authorisation procedure)
- Directive 2001/83/EC (Community code for medicinal products for human use)
- Arzneimittelgesetz (AMG) (German Medicinal Products Act)
- Arzneimittel- und Wirkstoffherstellungsverordnung (AMWHV) (German Ordinance on the Manufacture of Medicinal Products and Active Substances)
- ICH M4 (Common Technical Document, CTD)
- Regulation (EC) No 1234/2008 (variations)
Related topics
MDR Conformity →
Operational implementation of medical device authorization under the MDR (EU 2017/745)
IVD Consulting & IVDR Readiness →
Market authorization of in vitro diagnostics under the IVDR (EU 2017/746)
International Market Access →
In-depth strategies for third countries beyond the EU and the USA
Health Authority Interaction →
Scientific advice and structured authority communication in detail
PPWR Packaging Regulation →
Artwork, labeling and change control aligned with harmonized PPWR labeling under Art. 12
Have a concrete project?
Briefly outline your situation. We'll respond with an initial assessment, usually within one business day.
Prefer direct? +39 02 8904 1000
info@theentourage.it
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