Expert marketing authorisation support for life science products in the EU, UK and Switzerland
Accelerating MAA
Navigating the complex EU regulatory landscape requires more than checklists – it demands strategic insight, technical precision, and deep experience. Our regulatory consultants specialise in EU marketing authorisation support for pharmaceuticals, biotech products, and medical devices, offering comprehensive guidance across CMC, dossier preparation, submission strategy, and EMA procedures.
Whether you’re pursuing the centralised, decentralised, or mutual recognition route, we deliver tailored solutions that streamline approval timelines and ensure regulatory compliance. From early development through to final submission, we support your team at every step with hands-on expertise and a proven track record of successful MAAs.
How we support your MAA in Europe
We provide comprehensive, hands-on support to ensure a successful MAA submission, approval, and transition into the European market.
Project assessment & initiation
- Assess regulatory options and pathways
- Identify gaps between FDA, PMDA, NMPA, MFDS, MHRA approvals and EU requirements
- Advise on study design, bridging strategies, and scientific advice
Full MAA submission management
- Develop/review all MAA documentation to ensure regulatory compliance
- Compile, publish, and submit eCTD dossiers aligned with EMA standards on your behalf
- Manage regulatory interactions, deficiency responses, and authority meetings
CMC & Quality Assurance
- Manufacturing documentation, tech transfer, and variation services
- Develop an inspection-ready Quality Management System (QMS) for your EU entity
- Provide EU Qualified Person services
EU applicant solution
- Act as applicant until MA approval in the EU and manage post-approval commitments
- Maintain full regulatory and pharmacovigilance compliance
- Facilitate MAH transfer post-approval
- Support establishment of your EU entity
Pharmacovigilance & risk management
- Provide EU QPPV services as well as local PV activities as required
- Set up a compliant pharmacovigilance system
- Establish and maintain the Pharmacovigilance System Master File (PSMF)
Market Access & pricing strategy
- Develop HTA and payer engagement strategies for optimal pricing and reimbursement
- Support early market access and managed entry agreements
Key challenges for non-EU pharma companies entering Europe
Our team has the local intelligence and global expertise to guide you through the strict European regulations. Having an experienced project manager to lead the way, supported by subject matter experts, is instrumental for managing the challenges in your marketing authorisation application process.
Understanding and adapting to European regulatory requirements
- The European Medicines Agency (EMA) oversees centralised marketing authorisation, but national agencies (e.g., MHRA in the UK, Swissmedic in Switzerland) regulate other pathways.
- EU regulatory expectations often differ from those in the US and APAC, requiring companies to adapt their clinical, CMC, and pharmacovigilance data accordingly.
- Regulatory procedures vary, with centralised, decentralised (DCP), mutual recognition (MRP), and national procedures needing careful selection.
CMC and GMP compliance with EU standards
- The EU has strict GMP requirements, often more detailed than those in other markets.
- EU QP (Qualified Person) batch certification is mandatory, meaning manufacturers outside the EEA must work with an EU-based QP for batch release.
- Site inspections by EU authorities (EMA, national agencies) may be required, potentially delaying approvals.
Pharmacovigilance and risk management compliance
- The EU requires a local pharmacovigilance system, including an EU-based QPPV (Qualified Person for Pharmacovigilance) and a Pharmacovigilance System Master File (PSMF).
- Post-marketing surveillance and risk management plans (RMPs) often need adaptation from existing global strategies.
Market Access and pricing strategy in Europe
- European pricing is subject to strict national pricing and reimbursement regulations.
- HTA (Health Technology Assessment) processes vary across countries and must be factored into the launch strategy.
FAQ: EU Marketing Authorisation Applications (MAA)
Submissions for marketing authorisation in the EU must follow the structure of the (electronic) Common Technical Document (CTD/eCTD).
The dossier consists of five modules:
Module 1: Regional administrative information and prescribing information (EU): Cover letter, application form, information on the applicant/manufacturers, SmPC/labelling/package leaflet, information about the Experts, information relating to pharmacovigilance etc.
Module 2: Common technical document summaries:
- CTD Introduction
- Quality Overall Summary (QOS) – summarizing quality data from Module 3
- Nonclinical Overview and Summaries – summarizing non-clinical data from Module 4 (pharmacology, pharmacokinetics, and toxicology)
- Clinical Overview and Summaries – summarizing biopharmaceutics and associated analytical methods, clinical pharmacology studies, clinical efficacy and safety and synopses of individual studies from Module 5
Module 3: Quality – drug substance (general information, manufacture, characterization, control of drug substance, reference standards or materials, container closure system and stability), drug product (description and composition, pharmaceutical development, manufacture, control of excipients, control of drug product, reference standards or materials, container closure system and stability), appendices and regional information
Module 4: Non‑clinical study reports: pharmacology, pharmakinetics and toxicology.
Module 5: Clinical study reports: biopharmaceutic studies, studies pertinent to pharmacokinetics using human biomaterials, human PK and PD studies, efficacy and safety studies.
Additionally, depending on product type and regulatory context, other documents may be required – e.g. risk management plan, environmental risk assessments, information relating to paediatrics (e.g. pediatric investigation plans), manufacturing site / GMP declarations, variation/renewal forms, etc. The EMA “Marketing authorisation guidance documents” page lists all applicable guidance.
A regulatory affairs consultant adds value by ensuring the full dossier is compliant with EMA format (modules, eCTD metadata, regional/administrative requirements), by checking for completeness ahead of submission, and by reducing risk of validation delays or rejections.
- Pre-submission steps, e.g. the eligibility check – for medicines seeking the centralised procedure, an eligibility request (or letter of intent) is submitted to EMA well ahead of the planned application. Additional pre-submission steps may be required, depending on the product type and the regulatory context.
- Preparation of dossier in eCTD format (as described above) and submission via EMA’s eSubmission gateway / web client.
- Validation by EMA — to ensure all required documents are present before scientific review begins.
- Scientific evaluation by EMA’s Committee for Medicinal Products for Human Use (CHMP), and when applicable, Committee for Advanced Therapies (CAT), Pharmacovigilance Risk Assessment Committee (PRAC), Paediatric Committee (PDCO) and Committee for Orphan Medicinal Products (COMP). Evaluation typically takes up to 210 active days (excluding applicant response periods).
- CHMP opinion and EC decision – if the CHMP opinion is positive, the dossier is forwarded to the European Commission, which issues the legally binding marketing authorisation valid across the EU/EEA.
A regulatory affairs consultant can support by advising on timing (e.g. when to submit an eligibility request), coordinating dossier compilation across modules, managing the submission, handling interactions with rapporteurs, and expediting responses to regulatory questions – thereby helping to meet timelines and avoid costly delays.
- For ATMPs in the EU, the submission must follow the standard eCTD/CTD dossier layout, with Modules 1–5, like any other medicinal product.
- The evaluation must be conducted via the centralised procedure through EMA: the application is assessed by EMA’s CHMP together with the CAT for ATMP-specific aspects (quality, safety and efficacy of the advance therapy medicine).
- The dossier must include detailed data on e.g. characterization of cell/gene/tissue-based therapy, manufacturing process and controls, stability, nonclinical and clinical data suitable for advanced therapies, risk management plan, etc.
A regulatory affairs expert adds value by guiding ATMP specific regulatory strategy, ensuring that complex documentation (cell manufacturing, control, safety) meets EMA expectations, liaising with Authorities, and aligning development timelines with regulatory requirements to maximise chances of approval.
Yes – depending on the product and intended market reach. While many new, innovative or high complexity medicines (e.g. oncology medicinal products, medicines derived from biotechnology processes, ATMPs, orphan medicines) fall under the mandatory scope of the centralised procedure, applications for other medicines may be submitted viar:
- National procedure – for marketing in a single Member State
- Decentralised Procedure (DCP) – for simultaneous national authorisations in several Member States for a product not yet authorised anywhere.
- Mutual Recognition Procedure (MRP) – if a medicine is already authorised in one Member State and the MAH seeks recognition in others.
A regulatory affairs consultant helps by assessing which regulatory route is most suitable (centralised vs DCP/MRP/national), developing an efficient strategy tailored to the product type and business objectives, and coordinating submissions across jurisdictions to save cost and time.
Once an MA is granted, the MAH must comply with ongoing obligations: pharmacovigilance (safety monitoring and reporting), submission of periodic safety update reports, license renewals and submissions to fulfill commitments (e.g. submission of post-authorisation safety studies).
For any significant changes (quality, safety, efficacy), the MAH must submit variation or extension applications following the eCTD format.
A regulatory affairs expert supports post-MA lifecycle management by ensuring timely pharmacovigilance submissions, guiding variation strategy, managing renewals or extensions, and maintaining compliance with EMA requirements – thus safeguarding the MA and facilitating market continuity.
FAQ: Marketing Authorisation in Switzerland (Swissmedic)
All human medicinal products must be authorised by Swissmedic before they can be placed on the Swiss market. The applicant submits a complete dossier demonstrating quality, safety, and efficacy of the product. Swissmedic performs a scientific and regulatory assessment; if all legal and technical requirements are fulfilled, Swissmedic grants the marketing authorisation (MA) and approves the product information (for healthcare professionals and patients).
A regulatory affairs consultant adds value by defining the optimal regulatory pathway, ensuring dossier compliance with Swiss requirements, and managing interactions with Swissmedic to minimise approval delays.
Swissmedic requires a complete regulatory dossier covering administrative information, quality, nonclinical and clinical aspects of the medicinal product. For certain procedures, documentation must be submitted in CTD/eCTD format. Product information texts (Information for healthcare professionals and Patient information) are also mandatory. For applications relying on foreign approvals (e.g. under Article 13 of the Therapeutic Products Act), assessment reports from the reference authority must be included.
A regulatory affairs consultant ensures that all Swiss specific dossier elements, translations, and legal documentation are complete and correctly structured to avoid validation failure.
Swissmedic approval timelines depend on the type of procedure (new active substance, known active substance, simplified procedure). According to Swissmedic benchmarking data, review timelines vary by category and have been increasingly aligned with those of comparable international regulators for new active substances. However, clock-stops and additional data requests may extend the total timeline.
A regulatory affairs consultant adds value by planning realistic submission timelines, preparing high quality responses to Swissmedic questions, and reducing the risk of procedural delays.
Yes, under Article 13 of the Swiss Therapeutic Products Act (TPA) if the criteria are being fulfilled, Swissmedic may rely on assessments performed by recognised foreign authorities with a comparable control system (such as EMA or US FDA) for certain medicinal products. This simplified authorisation pathway can reduce the assessment workload for Swissmedic and hence the overall review timelines of the application, if Swissmedic resources allow for it. However, Swissmedic needs to agree on this regulatory pathway which depends on product type, regulatory status, and compliance with Swiss requirements.
A regulatory affairs consultant provides critical value by preparing a Swiss regulatory strategy and determining the eligibility for the Article 13 TPA authorization pathway, and coordinating the preparation of required submission documentation, including reference dossier from the foreign Authority.
FAQ: Marketing Authorisation in the UK
To market a human medicinal product in the UK, an application must be submitted to MHRA via its official Submissions Portal. The dossier must be submitted in the electronic Common Technical Document (eCTD) format.
Once submitted, MHRA assesses the application under the applicable legal basis (defined in the Human Medicines Regulations 2012, as mended).
A regulatory affairs consultant can support by preparing a fully compliant eCTD dossier, choosing the correct legal basis, and managing the submission process to MHRA – reducing risk of errors or delays.
Under MHRA, there are multiple routes to obtain a UK marketing authorisation:
- A UK-wide application, under the regular national MA procedure.
- The International Recognition Procedure (IRP) — available from 1 January 2024 -which allows MHRA to rely on a prior authorisation from one of its specified international “Reference Regulators” (e.g. EMA or other trusted regulators) to expedite UK approval.
A regulatory affairs expert can help evaluate which route (national vs IRP) is most efficient for your product, manage any document adaptations to UK-specific requirements and coordinate the submission.
For a standard MHRA application under UK law, the review timeline is typically up to about 150-210 days (excluding any clock-stops due to applicant responses), depending on the product type and whether unresolved issues remain.
For products submitted via IRP (when eligible), MHRA has indicated much shorter timelines – potentially around 60-110 days under certain circumstances (or somewhat longer depending on regulatory route) thanks to recognition of previous authorisations.
A regulatory affairs consultant adds value by helping you plan realistic timelines, preparing high quality submissions to minimise need for follow-up queries, and navigating IRP to accelerate time-to-market when possible.
Once MHRA grants a UK marketing authorisation, the holder must comply with ongoing regulatory obligations under UK law — including pharmacovigilance, maintaining product quality, labelling and packaging requirements, and submitting any variations or extensions for approval via MHRA’s variation/renewal procedures.
A regulatory affairs professional can support with ensuring continued compliance with UK regulatory requirements.
The IRP is advantageous when a medicinal product is already authorised by a trusted international regulator (a Reference Regulator), because MHRA may accept that prior authorisation and perform a streamlined “targeted assessment” instead of a full review. This can significantly shorten review timelines and simplify the authorisation procedure compared to a full national application.
A regulatory affairs consultant helps by preparing a regulatory strategy and assessing eligibility for IRP, preparing a complete and compliant application under IRP guidelines, and managing the regulatory procedure – which can accelerate UK approval and reduce cost and resource burden.
Your contact person
Delphine Guérin