Regulatory Strategy & Operations

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We plan, author, submit, and defend regulatory dossiers across the full product lifecycle, from initial classification and scientific advice through marketing applications, launch preparedness analysis and post-approval maintenance. That includes the roadmap, dossier compilation and eCTD publishing, authority interactions, and lifecycle updates.

Examples of How We Support

Below are examples to illustrate the kind of work we do day to day. The fastest way to find out more is usually a short call; this will help us to understand your specific challenges and to explore how we can help.

Cross-regional regulatory roadmap

You need a regulatory roadmap that works across regions. Your product is heading toward EU, US, or global filings and you need a cross-regional strategy that sequences scientific advice, clinical trial applications, orphan and paediatric requirements, HTA considerations, and marketing authorisations without conflicts or wasted effort.

MAA dossier compilation and submission

You're preparing a marketing authorisation application and need the full dossier compiled, published, and submitted. CTD Modules 1 through 5 need to be assembled from multiple teams, published in eCTD format, and submitted through the relevant authority portals, on time and reducing the risks of lengthy and inefficient validation times.

Authority assessment questions

You've received assessment questions from a health authority and need a structured response document. List of Questions, List of Outstanding Issues, RFIs, or clock-stop management, need a coordinated response strategy, revised documents, and a submission package turned around under deadline pressure.

Borderline product classification

Your product sits at a regulatory boundary. It could be classified as a medicinal product, a medical device, a cosmetic, or a food supplement, and you need a defensible classification with supporting documentation and authority engagement.

Regulatory representation

You need regulatory representation in the EU, UK, or Switzerland. EU Marketing Authorisation Holder (MAH) services, EU Authorised Representative, a US Agent for FDA interactions, or a Scientific Service (e.g., Drug Information Officer for Germany → Informationsbeauftragter) across EU jurisdictions.

Understanding Regulatory Strategy & Operations

Regulatory strategy and operations touch every part of the development programme. On this page, we cover the regulatory planning, pathway selection, dossier preparation, submission management, authority interactions, and lifecycle activities that sit at the centre of the process.

This page covers regulatory operations for medicinal products: marketing authorisation procedures, variations, and authority interactions that sit within the pharmaceutical regulatory framework. For medical device and IVD regulatory operations — conformity assessment, technical documentation under MDR/IVDR, and Notified Body coordination — see Medical Device Regulatory Services. For products at the boundary (combination products, borderline products), both teams work together, and the regulatory strategy determines which framework leads.

What We Do

We combine senior regulatory strategy with hands-on regulatory work including dossier authoring and creation. submission management, and authority dialogue. We don’t just write the strategy and hand it over; we actually execute it through to approval and beyond.

  • Develop global and regional regulatory strategies including pathway selection (centralised, decentralised, mutual recognition, national), risk-based sequencing with HTA considerations, and alignment of regulatory milestones with development timelines. In the UK, post-Brexit routes include the national procedure, the International Recognition Procedure (IRP), and the Innovative Licensing and Access Pathway (ILAP), each with distinct eligibility criteria and assessment timelines.
  • Plan and manage scientific advice across the full range of authority formats: EMA Scientific Advice, EMA PRIME and Innovation Task Force interactions, parallel EMA-HTA Joint Scientific Consultation (JSC), FDA meetings, MHRA Scientific Advice and Innovation Office engagement, and national competent authority consultations in EU member states. We also support scientific advice for ATMPs, orphan designation procedures, paediatric procedures with the PDCO, classification and borderline consultations under MDR/IVDR, and joint advice for drug-device combination products. We manage the procedure end to end: scheduling, agency liaison, team preparation including mock Q&A sessions, meeting attendance and real-time support, and post-meeting authoring and review of minutes to identify commitments and implications for the development plan.
  • Author and compile CTD dossiers (Modules 1 through 5) for marketing applications, clinical trial applications (CTA/IND/IMPD), Orphan Drug Designation (ODD), Paediatric Investigational Plans/Waivers (PIP), and any lifecycle submissions. Coordinate inputs across CMC, clinical, nonclinical, and PV teams.
  • Publish and submit eCTD packages through EMA, FDA, MHRA, Swissmedic, and national authority portals. Manage validation, formatting, and portal-specific requirements including the transition to eCTD v4.0 for centralised procedures.
  • Manage authority interactions and responses: assessment report reviews, RFI and clock-stop response strategies, response packages, clarification meetings, and oral explanation preparation.
  • Plan and execute post-approval lifecycle activities: variations under the revised EU Variations Guidelines (effective 15 January 2026), renewals, line extensions, PSUR/PBRER submissions, and SmPC/labelling updates.
  • Manage Paediatric Investigation Plans (PIP) and Stepwise PIP (sPIP) from initial assessment through PDCO agreement and lifecycle maintenance. Under EU Regulation (EC) No 1901/2006, a PIP or waiver is mandatory for all new Marketing Authorization applications and certain variations. We assess PIP applicability and timing, prepare and compile the full PIP application for submission via the IRIS platform, manage the PDCO review procedure (approximately 120 days excluding clock-stops), coordinate responses to lists of questions, and handle modifications to agreed PIPs throughout the product lifecycle. We prepare waiver applications where no paediatric utility exists, and manage deferral requests to align paediatric study timelines with adult development. Completed PIPs can unlock incentives including a six-month Supplementary Protection Certificate extension and, for orphan medicines, a two-year extension of market exclusivity. For medicines developed specifically for children, we support Paediatric-Use Marketing Authorisation (PUMA) applications, which provide ten years of market protection. For UK-specific PIP requirements (MHRA process, EU PIP reliance strategy), see the regenold UK local page.
  • Plan and execute Rx-to-OTC reclassification programmes from feasibility assessment through regulatory approval and post-switch implementation. A successful switch requires demonstrating that the product can be used safely without medical supervision: sufficient safety margin, a self-recognisable indication, straightforward dosing, and labelling that supports safe self-selection. We conduct feasibility assessments evaluating clinical and safety data, regulatory precedent, and labelling suitability. Where required, we design and manage evidence development programmes including label comprehension studies, self-selection studies, and actual-use studies. We prepare the reclassification dossier with clinical and safety narratives, human factors evidence summaries, and benefit-risk assessments. We manage the procedural route, whether MHRA reclassification in the UK, Article 74a variation in the EU, or equivalent pathways in other jurisdictions, including scientific advice, advisory committee preparation, and public consultation stages. Post-approval, we support labelling implementation, pharmacovigilance system adaptation for OTC status, and promotional material review for compliance with OTC advertising codes.
  • Conduct classification and borderline assessments: mode-of-action evaluation, regulatory classification for products at the interface of medicinal, device, cosmetic, or food regulation, and preparation of supporting dossiers for authority engagement.
  • Provide regulatory representation: MAH services, EU Authorised Representative, ODD sponsorship, US Agent for FDA, and local Scientific Service (e.g., Drug Information Officer/Informationsbeauftragter in Germany) across multiple EU jurisdictions. EMA SME status applications and management of associated fee incentives.

Our Workstreams

We structure our regulatory work into clear workstreams so responsibilities and handoffs are well defined.

Regulatory Strategy and Roadmap

Product classification and legal status determination. Global/regional regulatory roadmaps. Pathway selection: EU (CP, DCP, MRP, national), UK (national, IRP, ILAP), US (NDA, BLA, 505(b)(2)), and global routes via regulanet®. Orphan Drug Designation requests. Paediatric Investigation Plans: PIP/waiver assessment, PDCO submission and procedure management via IRIS, deferral and modification management, SPC extension and orphan exclusivity incentive tracking, PUMA applications. Rx-to-OTC switch strategies: feasibility assessment, regulatory precedent analysis, evidence development planning (label comprehension, self-selection, actual-use studies), reclassification dossier preparation, authority engagement (MHRA, EU Article 74a, advisory committees), and post-switch implementation (labelling, PV adaptation, OTC promotional compliance).

Scientific Advice and Early Interactions

EMA Scientific Advice (SAWP/CHMP), FDA meetings, MHRA Scientific Advice and Innovation Office, National Scientific Advice, ATMP-specific advice through EMA's Committee for Advanced Therapies, PDCO interactions for PIPs, orphan eligibility discussions, and joint drug-device combination product consultations. Briefing document authoring (CMC, clinical, nonclinical, statistical, and device-specific arguments). Question framing and company position development. Mock Q&A sessions and meeting rehearsals. Meeting attendance and real-time support. Post-meeting authoring and review of minutes, identification of regulatory commitments, and integration of authority feedback into development plans. Cross-regional SA coordination through regulanet® to align questions and justifications across divergent frameworks.

Submission Planning and Execution

CTA/IND/IMPD and MAA/NDA planning. eCTD compilation and publishing (including eCTD v4.0 readiness). Translation coordination. Health authority portal management. Validation and formatting compliance. Gateway submission and troubleshooting (IRIS, EMA Gateway, CESP, MHRA portal).

CTD Authoring and Documentation

Full CTD authoring and integration (Modules 1 through 5). Region-specific Module 1 preparation. Module 2 summaries. Borderline classification dossiers. Briefing books and position papers. Dossier readiness and gap analysis: cross-module assessment of CTD completeness against target authority requirements, covering quality (Module 3), nonclinical (Module 4), and clinical (Module 5) data adequacy. Structured findings classified by regulatory impact (critical, major, minor) with remediation recommendations and submission readiness timelines. For combination products and devices, gap analysis extends to MDR/IVDR technical documentation and Article 117 requirements.

Lifecycle and Post-Approval Management

Variations (under revised EU Variations Guidelines from 15 January 2026), renewals, line extensions. SmPC/PIL updates and labelling management. QRD compliance. PSUR/PBRER coordination. Post-marketing commitments.

Representation and Legal Services

MAH services (EU, UK, CH). EU Authorised Representative. US Agent for FDA. Scientific Service (e.g., Drug Information Officer) across EU jurisdictions. ODD sponsorship. EMA SME applications and incentive management.

Development Journey

Regulatory strategy is a continuum. The focus shifts at each phase, but the need for coordinated planning and execution runs from first concept through post-market lifecycle management.

Discovery & Concept

Clarify regulatory classification and legal status. Assess feasibility of regulatory pathways. Advise on initial nonclinical and CMC requirements.

Product Type Considerations

Regulatory pathways and documentation requirements differ by product type. Recognising these differences early prevents mismatched strategies and avoids unnecessary work.

Small Molecules

Well-established pathways, but attention needed for quality requirements (impurities, stability, nitrosamines), bioequivalence data for generics, and alignment with current ICH and EMA guidelines.

Borderline Products

Products at the interface of medicinal, device, cosmetic, or food regulation require mode-of-action evaluation, legislative assessment, and authority engagement to confirm the regulatory pathway.

Combination Products

Primary mode of action determines the lead regulatory framework. For drug-led combination products, we manage the pharmaceutical regulatory dossier and coordinate with the device regulatory team on Article 117 submissions. For device-led combination products, the device team leads the conformity assessment; we provide the pharmaceutical input required under the MDR framework. Both are regenold teams, so the coordination is internal.

Biologics & ATMPs

Scientific advice is often critical to align on nonclinical models and potency assays. Regulatory roadmaps must account for PRIME or RMAT designations, comparability data requirements, and post-approval commitments.

Digital Health & SaMD

Classification depends on intended use and software functionality. Must address MDR/IVDR compliance, EU AI Act requirements, and FDA expectations for AI/ML-based devices.

Sample Deliverables

These are typical outputs from our clinical development engagements.

icon Global regulatory roadmap with risk-based sequencing, scientific advice milestones, and filing strategy across EU, US, and Japan.
icon EMA Scientific Advice package: briefing book, list of questions and company position, rehearsal support, procedure handling and, if requested, meeting preparation and management, and post-meeting implementation plan.
icon Complete CTD dossier (Modules 1 through 5) compiled and published in eCTD format for initial MAA or NDA submission.
icon Clock-stop response package: consolidated response strategy, revised document sections, annotated texts, and question tracking log.
icon Dossier gap analysis report: cross-functional assessment of CTD completeness across Modules 1–5, with findings classified by severity (critical, major, minor), recommended remediation actions, timeline dependencies, and submission readiness assessment.
icon Rx-to-OTC switch dossier: reclassification justification, comparative benefit-risk analysis, and multi-country implementation plan.
icon Borderline classification dossier: mode-of-action analysis, legislative assessment, recommended regulatory pathway, and authority correspondence record.
icon Variation package under the revised EU framework: classification assessment, updated documentation, and submission through EMA/national portals
icon SmPC, PIL, and labelling package: QRD-compliant texts, multilingual translations, linguistic review, and mock-up/specimen submissions
icon Marketing authorisation application package. Complete project management and dossier compilation for centralised, decentralised, mutual‑recognition or national marketing authorisation procedures.

Example Projects

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Mid-Sized US Company: Integrated Regulatory Roadmap and MAA

A mid-sized US company needed an integrated regulatory roadmap including ODD and PIP filing strategy and submission. We managed dossier compilation and MAA handling, interactions with EMA ensuring a time-effective procedure, and a successful competitor race for first orphan indication medicinal product through identification of key elements showing clinical superiority.

Planning a Submission, Preparing for Scientific Advice, or Managing a Lifecycle Change?

Tell us about your product and your regulatory timeline, and we'll outline how we can help.

Speak with an Expert

When should we request scientific advice?

Before pivotal decisions that lack clear guidance. The most common timing is before key nonclinical studies, before first-in-human trials, or before finalising the Phase III design. Scientific advice is prospective and non-binding, but it significantly reduces the risk of unexpected authority questions during the marketing application assessment.

Can the same dossier be used for EMA and FDA?

Core data sets are often shared, but the presentation, emphasis, and Module 1 requirements differ. We develop harmonised core modules and adapt region-specific sections so you avoid duplicating data generation while meeting each agency's expectations.

What changed with the EU Variations framework?

The revised Variations Regulation (EU) 2024/1701 applied from 1 January 2025. New EC Variations Guidelines took effect on 15 January 2026 with updated classification categories and a new electronic application form. We manage the transition for clients, including reclassification of pending changes and alignment with the updated procedures.

What is the difference between centralised, decentralised, and national procedures?

The centralised procedure (CP) results in a single EU-wide marketing authorisation and is mandatory for certain product types (e.g., biotech, orphan, HIV, cancer). The decentralised procedure (DCP) and mutual recognition procedure (MRP) produce national authorisations through coordinated assessment. The right choice depends on your product type, target markets, and commercial strategy.

How do you handle borderline product classification?

We assess the product's primary mode of action, map it against the definitions in pharmaceutical, device, cosmetic, and food legislation, and prepare a classification dossier with supporting evidence. Where the classification is contested or ambiguous, we engage directly with competent authorities to resolve it before committing to a regulatory pathway.

How do you obtain EMA SME status, and why is it beneficial?

Companies must meet size and turnover criteria and register with the EMA SME office. The EU provides administrative and financial incentives to SMEs to promote innovation. We prepare applications and advise on how to leverage fee reductions and scientific advice support.

Do you submit dossiers, or only prepare them?

We do both. We author, compile, publish in eCTD format, submit through authority portals, and manage the entire interaction cycle including assessment questions, clock-stops, and post-approval submissions. We don't hand off a document and walk away.

What is the role of a Drug Information Officer (DIO)?

Under Directive 2001/83/EC, marketing authorisation holders must have a scientific service responsible for information about their medicinal products. In several EU countries this role is formalised as an Information Officer (German: Informationsbeauftragter) who ensures that labelling, package leaflets and advertising are accurate, not misleading and consistent with the marketing authorisation. We provide this role across multiple jurisdictions.

How do you coordinate regulatory activities across multiple EU countries?

For multi-country submissions and post-approval activities, we work with local regulatory experts through regulanet®, our global network of independent service providers in 90+ countries. This covers national requirements such as translations, local authority preferences, and procedural nuances.

What is the difference between regulatory strategy and regulatory operations?

Strategy defines the regulatory pathway, the evidence requirements, and the sequencing of submissions across markets. Operations executes that plan: preparing the dossier, compiling and publishing in eCTD, submitting through authority portals, managing assessment questions, and handling post-approval variations. We do both. The same team that designs the strategy also runs the operations, which means the plan is built by people who know what it takes to execute it.

Is scientific advice legally binding?

No. Scientific advice from EMA, MHRA, or national competent authorities is not legally binding on either the authority or the company. However, agencies expect companies to follow the advice or provide well-documented reasons for deviating. Consistency with scientific advice is particularly scrutinised for pivotal study design, endpoint justification, manufacturing comparability, and paediatric commitments. We help clients assess when deviation is reasonable and how to document the rationale so it holds up during assessment.

Is an agreed Paediatric Investigation Plan mandatory if my product does not have a paediatric indication?

Yes, in the European Union, an agreed Paediatric Investigation Plan (PIP) is generally mandatory for all new marketing authorisation applications, variations, or line extensions for medicinal products, regardless of whether a paediatric indication is intended. The purpose is to ensure that the potential benefits and risks for use in children are considered.

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