Services

Success in pharmaceutical regulations rely on up-to-date knowledge of legal requirements, strategic planning, and precise execution. We provide comprehensive regulatory support to ensure that medicinal products meet all applicable standards and reach the market efficiently and compliantly.

Services:

• new marketing authorization applications
• renewals
• variations
• eCTD dossier compilation and submission
• lifecycle management
• regulatory and dossier audits
• strategic consulting
• translations of product information
• mock-up review
• post-marketing compliance

Our expert team navigates the complexities of regulatory procedures with tailored solutions that align with both legal requirements and business objectives. Whether for national or international submissions, we optimize every step of the process for speed, accuracy, and success.

A well-defined regulatory strategy is crucial for a successful product launch and sustained market presence. Our experts develop tailored regulatory roadmaps that align with your business objectives while ensuring full compliance with national and international requirements.

From early-stage planning and risk assessment to regulatory strategy development and market entry requirements, we provide comprehensive, end-to-end support – driving approvals and enhancing operational efficiency.

Whether you are launching a new product or expanding into new markets, RADAYDRUG transforms regulatory complexity into strategic advantage.

Meeting regulatory expectations can be complex, but early scientific advice helps avoid unnecessary delays, reducing costs, and increasing the likelihood of successful outcomes. We support Clients in preparing for and conducting meetings with regulatory authorities, ensuring alignment with both EU and national regulatory requirements from the earliest stages of development.

Our consulting services offer strategic guidance across clinical and non-clinical documentation, quality standards, and dossier development – laying the groundwork for a smooth and efficient approval process.

With decades of experience and strong professional relationship with several regulatory authorities across Europe, we facilitate clear communication and effective collaboration.

Whether you are planning early-phase consultations or formal scientific advice procedures, our structured, expert-led support helps accelerate development timelines and strengthen regulatory compliance.

A structured, regulation-aware development process is essential for a successful market launch. We offer end-to-end support across all stages of product development for pharmaceuticals, medical devices, food supplements, and other health-related products.

Services:

• strategy development planning
• expert consulting on clinical and non-clinical documentation
• defining quality requirements
• compiling regulatory-compliant documentation
• pre-market compliance reviews

We help ensure your product development is not only aligned with regulatory expectations but also optimized to meet business objectives – accelerating time-to-market while minimizing risk.

A regulatory gap analysis is a critical step in ensuring your product meets compliance requirements before submission. Our experts conduct a thorough review of available data, documentation, and regulatory strategy to identify missing or insufficient information that could lead to delays or rejections.

The purpose of a gap analysis is to detect missing or insufficient information to reduce the risk of delays or rejections and strengthen the overall regulatory approach.

Our authority meeting consulting services are often integrated into this process, ensuring that identified gaps are addressed proactively and in alignment with regulatory expectations.

We provide clear, actionable recommendations to bridge these gaps efficiently, optimizing your submission strategy and reducing risks. With our proactive approach, you can confidently move forward in the regulatory process with a well-prepared dossier.

A successful marketing authorization application begins with a thoroughly prepared and fully compliant dossier. We offer pre-submission dossier assessment services to identify potential gaps and ensure alignment with regulatory expectations – minimizing the risk of authority objections and delays.

Services:

• identification of missing data and regulatory non-conformities
• review of dossier structure and content (Module 1-5)
• risk assessment and development of compliance strategies
• actionable recommendations for dossier alignment and submission readiness

With our expert support, your application will be submission ready – well-structured, compliant and optimized for a smooth approval process.

Obtaining Marketing Authorisation for medicinal products in the European Union is a complex process that requires strategic planning and strict regulatory compliance. Selecting the optimal authorisation pathway is critical to achieving timely and efficient market access.

Services:

• regulatory consulting during product development
• preparation of IMPD (Investigational Medicinal Product Dossier)
• medical writing (clinical and non-clinical overviews, medical summaries)
• selection of the most suitable authorisation procedure (National, MRP, DCP, Centralised)
• dossier preparation and submission (eCTD format)
• communication with regulatory authorities and response to queries
• full project management throughout the process

With our deep regulatory expertise and hands-on experience, we ensure your product meets all requirements and progresses smoothly through national and EU-level authorisation procedures.

Ensuring the accuracy and regulatory compliance of product information documents — such as the Summary of Product Characteristics (SmPC), Patient Information Leaflet (PIL), and labelling (LAB) – is essential for both patient safety and regulatory approval. We provide expert review and strategic support to ensure that all product-related materials meet the expectations of EU and national authorities, as well as pharma sector standards.

Services:

• professional and linguistic review of SmPC, PIL, and LAB
• verification against European Union and national regulatory frameworks
• updates and modifications aligned with authority feedback
• mock-up and artwork review prior to production
• strategic consulting to optimize documentation quality

Accurate and well-prepared Product Information not only ensures compliance but also supports safe and effective use, strengthening your product’s position throughout its lifecycle.

Effective lifecycle management is critical for maintaining regulatory compliance and long-term market presence. We provide comprehensive support to ensure that your products remain aligned with evolving regulatory requirements throughout their entire lifecycle.

Services:

• managing variations and renewals
• updating and reviewing product information (SmPC, PIL, labels)
• implementing safety measures and risk minimisation strategies
• strategic consulting tailored to regulatory expectations
•  continuous monitoring and updating of documentation requirements

With our expert guidance, you can confidently navigate regulatory obligations focusing on innovation and business growth.

Notification of food supplements and foods for special medical purposes is a mandatory regulatory requirement in the European Union. We provide end-to-end support to ensure full compliance and a smooth notification process.

Services:

• review of documentation required for notification
• identification of missing data or inconsistencies
• verification of health claims
• support in developing compliant label texts
• full management of the notification procedure
•  regulatory consulting to ensure compliance

All cosmetic products must be registered in the EU before being placed on the market. We support our Clients in preparing and managing the registration process in full compliance with applicable regulations.

Services:

• review of registration documentation
• identification of missing data or inconsistencies
• assistance with label text development
• full management of the registration process
• regulatory consulting to ensure compliance
• support with cosmetovigilance obligations

We help our Clients bring their products to market efficiently, meeting all relevant regulatory expectations.

For marketing authorization holders, pharmacovigilance is not only a regulatory obligation but a fundamental component of patient safety. European Union and national legislation require the continuous operation of a robust and well-documented pharmacovigilance system throughout the entire lifecycle of a medicinal product.

We provide expert support in establishing, maintaining, and operating pharmacovigilance systems in full alignment with Good Pharmacovigilance Practices (GVP) and applicable regulatory requirements.

Services:

• pharmacovigilance system setup and maintenance, including QPPV provision
• signal detection, evaluation, and risk management
• preparation of Periodic Safety Update Reports (PSUR)
• development and maintenance of Risk Management Plans (RMP)
• safety database management
• medical literature monitoring
• coordination of global and local PV partners (e.g. local QPPV network)
• integration of PV activities into the Quality Management System (QMS)
• support in regulatory communication (e.g. CAPA responses, authority queries)
• pharmacovigilance system audits and gap analysis
• development and revision of SOPs and internal policies
• Pharmacovigilance in Clinical Trials
• audit preparation and regulatory compliance support

Our goal is to ensure that pharmacovigilance systems not only meet formal requirements but also function as effective tools for drug safety and support the further development.

EudraVigilance is the European Medicines Agency’s (EMA) central database for collecting and evaluating reports of suspected adverse reactions to medicinal products across the European Economic Area. The system plays a vital role in monitoring drug safety and identifying potential risks in a timely and structured manner.

We assist our Clients in fulfilling their EudraVigilance obligations and in using the platform effectively as part of a robust pharmacovigilance system.

Services:

• registration and user access management (e.g. EVWEB access, role assignment)
• processing and submission of adverse event reports
• setup and validation of ICSR workflows
• structuring and maintenance of xEVMPD data (e.g. product entries, updates, validation)
• internal training on EudraVigilance operations, including GVP modules and reporting obligations
• signal detection and evaluation based on incoming safety data

With our experience, we help Clients meet their EudraVigilance obligations and make effective use of the system to continuously monitor and maintain the safety profile of their products.

Under EU pharmacovigilance legislation, every Marketing Authorisation Holder (MAH) must appoint a Qualified Person for Pharmacovigilance (EU QPPV) who is permanently and continuously available within the EU. In addition, many countries – both within and outside the EU – require a Local QPPV (LPPV) to ensure compliance with national pharmacovigilance obligations and to liaise with local authorities.

The QPPV plays a central role in maintaining the pharmacovigilance system, overseeing safety data, and ensuring regulatory compliance. Our experienced professionals provide both EU and local QPPV services tailored to the specific needs of each market and regulatory environment.

Services:

• provision of EU QPPV in full compliance with GVP requirements
• appointment of local QPPV / LPPV based on country-specific regulations
• designation and training of deputy QPPVs
• QPPV registration and authority notifications
• 24/7 availability

While pharmacovigilance is globally regulated, national requirements and procedures often vary. In EU member states, appointing a local pharmacovigilance contact person and maintaining a functioning local system is mandatory. These systems ensure effective oversight of drug safety and facilitate communication with national authorities.

Our team has extensive experience supporting national pharmacovigilance operations across both EU and non-EU countries. We help our Clients navigate local regulations and integrate national requirements into their global PV systems seamlessly.

Services:

• provision of local pharmacovigilance contact person (LPPV)
• adverse event case management and reporting to national authorities
• monitoring and evaluation of national medical literature
• continuous tracking of local PV legislation and updates
• development of SOPs and procedures
• preparation for local authority inspections and audits
• integration of national PV systems into global frameworks
• support for local risk minimization activities
• regulatory communication and fulfilment of local reporting obligations

Our goal is to ensure that Clients operate compliant and efficient pharmacovigilance systems in every country – aligned with local expectations and harmonized globally.

Under GVP guidelines, the PSMF must accurately reflect the system’s structure, processes, and compliance status.

Maintaining an up-to-date and audit-ready PSMF is essential not only for regulatory compliance but also for ensuring transparency and internal quality assurance. Our services help Clients ensure that their documentation is always aligned with current expectations.

Services:

• preparation and maintenance of PSMF
• audit and quality review of existing PSMFs
• Preparation of Global PSMF: harmonisation of PSMF content across multiple national systems

Aggregated, periodic pharmacovigilance reports – such as PSURs and DSURs – play a key role in the continuous evaluation of medicinal product safety, the timely identification of risks, and ensuring regulatory compliance both in developing phase and during post-marketing periods.

Our experienced team supports Clients in the preparation, submission, and regulatory management of aggregated reports, ensuring full compliance with current GVP and ICH requirements.

PSUR – Periodic Safety Update Report
A PSUR is a detailed, aggregated safety report required for authorised medicinal products to be submitted in defined periods. It includes the analysis of adverse events, cumulative safety data, and newly identified risks.

In the EU and other regulated markets, PSURs are mandatory to ensure ongoing safety monitoring.

Services:

• preparation and submission of PSURs in accordance with GVP
• benefit–risk evaluation and signal detection
• coordination with regulatory authorities and submission management
• handling of PSUSA (EU single assessment) and national review procedures

DSUR – Development Safety Update Report
The DSUR is an annual safety report for investigational medicinal products used in clinical trials. It includes an overview of unexpected events, ongoing studies, and newly identified safety concerns. DSURs are required under ICH E2F guidelines to protect clinical trial participants and ensure regulatory compliance.

Services:

• preparation of DSURs in line with ICH E2F guidelines
• collection and evaluation of clinical trial safety data
• benefit–risk assessment across all stages of development
• support for international submission and regulatory compliance

From report preparation to regulatory review, we provide end-to-end support to ensure that all safety information is submitted accurately, on time, and in full compliance with applicable standards.

The Risk Management Plan (RMP) is a mandatory regulatory document required throughout the entire lifecycle of a medicinal product and forms an integral part of the marketing authorisation dossier. Its purpose is to identify, assess, minimize, and monitor potential risks – ensuring patient safety and regulatory compliance.

An RMP is not a static document, but a dynamic system that must be regularly updated to reflect new safety data and evolving regulatory expectations. With experience gained from preparing hundreds of RMPs, our team delivers tailored, practical, and authority-accepted solutions for a wide range of regulatory scenarios – from initial submissions to post-authorisation obligations and newly emerging safety concerns.

Services:

• RMP development and updates – in full compliance with GVP Module V and national requirement
• lifecycle management – regular updates based on new safety data and regulatory changes
• regulatory review support – handling authority questions, implementing required modifications, and preparing responses
• design and evaluation of risk minimization measures (RMMs) – including educational materials, patient guides, and targeted programs
• RMP audit and quality review – assessment and harmonization of existing documentation
• Support for international submissions – including non-EU formats and country-specific annexes

With our expert support, the RMP becomes more than a compliance tool – it becomes a strategic asset for proactive risk management and long-term product success.

Accurate and comprehensive literature searches are essential for ensuring regulatory compliance, pharmacovigilance, and evidence-based decision-making.

Regulatory authorities – including the EMA and national agencies – require systematic surveillance of scientific literature to identify adverse events, safety signals, and emerging data.

Our experienced team provides targeted, systematic literature monitoring services tailored the needs of the pharmaceutical, medical device, cosmetic, and nutraceutical industries – both globally and locally.

Services:

• systematic literature searches – regular screening of scientific databases (e.g. PubMed, Embase, Medline)
• pharmacovigilance literature monitoring – identification of adverse events, ICSRs, and safety signals
• local literature surveillance – monitoring of non-indexed, country-specific sources in local languages
• regulatory documentation support – literature collection for PSURs, DSURs, RMPs, and clinical, non-clinical summaries
• customized search strategies – custom protocols aligned with regulatory and scientific requirements
• data analysis and reporting – critical evaluation, structured summaries, and authority-ready formats
• translation and full-text procurement – access to and linguistic support for international publications

Our services ensure that Clients receive timely, accurate, and actionable insights – supporting compliance, safety, and informed decision-making in a dynamic regulatory environment.

Compliance audits are essential to ensure that systems and processes align with regulatory expectations, industry standards, and best practices. Audits are not just about identifying gaps – they are opportunities to improve, reduce risk, and drive operational excellence.

We provide comprehensive audit services to help Clients identify weaknesses, implement corrective actions, and maintain long-term compliance.

Services:

• pharmacovigilance audits – full system and process reviews to ensure drug safety compliance
• regulatory documentation and process audits – evaluation of dossiers and procedures for medicinal products, medical devices, and cosmetics
• quality management system audits – internal and third-party audits to assess QMS effectiveness and compliance
• CAPA management support – development and tracking of corrective and preventive actions
• audit reporting and follow-up – clear, actionable audit reports and hands-on implementation support
• audit readiness preparation – targeted preparation for authority or partner audits, including mock audits

Our audit services empower Clients to go beyond compliance – enhancing transparency, efficiency, and trust across their operations.

In today’s complex regulatory landscape, ensuring the safety and performance of medical devices requires a robust and responsive vigilance system. The goal is to detect and manage serious incidents, support risk mitigation, and maintain product compliance throughout the entire lifecycle.

Our expert team covers every aspect of the vigilance process – from incident reporting and trend analyses to post-market surveillance (PMS). We provide tailored solutions that align with each Client’s product portfolio, market presence, and strategic objectives.

Services:

• Incident reporting and trend analysis – evaluation and reporting of adverse events, identification of safety trends
• PMS system development and management – full support in designing and maintaining post-market surveillance systems
• preparation of PSUR and SSCP – authoring of Periodic Safety Update Reports and Summary of Safety and Clinical Performance
• support for risk mitigation actions – assistance with Field Safety Corrective Actions (FSCAs) and related communications
• regulatory communication and compliance – submission of reports, handling of authority queries, and audit readiness

With our support, Clients can ensure that their devices remain safe, effective, and fully compliant – enabling smooth market access and sustained performance.

In the cosmetics industry, product safety and compliance are essential for building consumer trust and maintaining market presence. Cosmetovigilance focuses on identifying, assessing, and managing undesirable effects, while ensuring the safe use of products throughout their lifecycle.

Our expert team provides comprehensive cosmetovigilance services to support Clients in managing risks, maintaining safety documentation, and operating effective post-market surveillance systems – all while protecting brand integrity and ensuring long-term competitiveness.

Services:

• monitoring and reporting of undesirable effects– collection, evaluation and submission of adverse event reports
• Product Information Files (PIF) management – compilation and maintenance of complete safety documentation
• safety assessments – expert evaluation of ingredients and finished products
• Post-Market Surveillance (PMS) – ongoing product monitoring and documentation to identify and mitigate potential safety risks
• expert consultation

With our support, Clients can be confident that their cosmetic products meet the highest safety standards – while strengthening consumer trust and maintaining a strong market position.

Bringing a medical device to the European market requires proven safety, performance, and full regulatory compliance. We provide comprehensive support to help our Clients navigate the CE marking process and maintain compliance throughout the product lifecycle.

Services:

• regulatory support for manufacturers, distributors, and importers
• coordination of conformity assessment and certification processes
• assistance with technical documentation and clinical evaluation
• communication with Notified Bodies
• EUDAMED and national registrations
• post-market surveillance and vigilance system management
• strategic consulting to maintain regulatory compliance

We work closely with our Clients to ensure their devices meet the requirements of MDR or IVDR and are ready for successful market access across the European Economic Area.

In today’s complex regulatory landscape, ensuring the safety and performance of medical devices requires a robust and responsive vigilance system. The goal is to detect and manage serious incidents, support risk mitigation, and maintain product compliance throughout the entire lifecycle.

Our expert team covers every aspect of the vigilance process – from incident reporting and trend analyses to post-market surveillance (PMS). We provide tailored solutions that align with each Client’s product portfolio, market presence, and strategic objectives.

Services:

• Incident reporting and trend analysis – evaluation and reporting of adverse events, identification of safety trends
• PMS system development and management – full support in designing and maintaining post-market surveillance systems
• preparation of PSUR and SSCP – authoring of Periodic Safety Update Reports and Summary of Safety and Clinical Performance
• support for risk mitigation actions – assistance with Field Safety Corrective Actions (FSCAs) and related communications
• regulatory communication and compliance – submission of reports, handling of authority queries, and audit readiness

With our support, Clients can ensure that their devices remain safe, effective, and fully compliant – enabling smooth market access and sustained performance.

A well-prepared and clearly structured technical file is essential for the successful regulatory approval for medical devices. We support the creation and maintenance of technical documentation, ensuring accuracy, completeness, and readiness for submission.

Services:

• compilation of design and manufacturing data
• risk assessment and clinical evaluation
• post-market surveillance documentation
• continuous update and compliance monitoring

With our expertise, your technical file will meet the highest regulatory standards, supporting a smooth path to CE marking and market access.

We regularly prepare the required sections of the Investigational Medicinal Product Documentation (IMPD), including the chemical (manufacturing) documentation as well as non-clinical and clinical summaries.

Services:

• safety database management
• processing, narrative preparation, and reporting of SAE/SUSAR cases to various authorities (EudraVigilance, FDA ESG)
• preparation of Development Safety Update Report (DSUR) and aggregate reports (Line listings)
• pre-marketing signal management (Analysis of Similar Events: AOSE, literature screening and assessment)
• compilation of required documentation (e.g. Safety Management Plan, SOP, work instructions)