How do you build a viable regulatory strategy for your products across Pharma, Biotech, MedTech and IVD?
We develop product-specific regulatory roadmaps across all domains, from classification and authority strategy through the dossier (CTD/eCTD or technical documentation) to lifecycle management with variations and renewals. Depending on the product, the governing framework is the German Medicinal Products Act (AMG) and EMA procedures, or the Medical Device Regulation (EU) 2017/745 and the IVDR (EU) 2017/746. The essential factor is not a missing dossier but a missing strategy: if you do not define classification, regulatory pathway and evidence requirements before you start writing, you build documents that have to be reopened during the procedure.
- Pharma
- Biotech
- MedTech
- IVD
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: 2026-06-12
Regulatory affairs brings together technical, clinical and legal requirements across the entire product lifecycle. The points at which projects most often stall are not the regulations themselves, but their sequence and their concurrency:
- Divergent requirements from multiple authorities: the EMA via the centralised 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-authorisation changes tie up resources: variations under Regulation (EC) No 1234/2008, renewals and line extensions must be classified and submitted on time, otherwise they jeopardise the authorisation 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 centralised 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.
Authority Communication & Scientific Advice
Preparation and support for scientific advice and pre-submission meetings, including briefing book and list of questions; the outcome is documented authority feedback on the development strategy.
Learn more →Dossier Preparation & Review
Preparation and review of marketing authorisation dossiers in CTD/eCTD format (ICH M4) for medicinal products, or technical documentation for MDR/IVDR, with a cross-module consistency check as a deliverable.
Learn more →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.
Lifecycle Management & Variations
Management of variations under Regulation (EC) No 1234/2008, renewals and line extensions, with classification of the change type and a timeline, documented per authorisation.
Learn more →Interim Regulatory Affairs Management
Filling staffing gaps with experienced RA experts on a temporary, project or freelance basis; what is handed over is a documented status of work rather than open matters.
Learn more →How we work together
What it comes down to
Regulatory affairs is not a documentation problem but a sequencing problem. Three decisions have to be in place before the first page is written: the regulatory pathway (centralised 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. Those who define these three before the dossier under ICH M4 or the technical documentation is created build modules that survive the procedure. Those who leave them open build modules that have to be reopened after the first round of authority feedback.
The second bottleneck is concurrency. 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. This is exactly where we come in: strategy and roadmap up front, early authority engagement through scientific advice before submission, and a dossier structured so that maintenance across the lifecycle stays inexpensive, rather than expensive 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 authorisation.
Lifecycle Maintenance
Established variations and renewal process that continuously safeguards the authorisation 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; those who submit without this alignment only learn 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 jeopardise the authorisation 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.
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 - centralised 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)
- https://theentourage.de/expertise/regulatory-affairs/ (existing page content, revised)
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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 (centralised 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 Consulting →
Operational implementation of medical device authorisation under the MDR (EU 2017/745)
IVDR Readiness →
Market authorisation 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
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