Regulatory Affairs Services
From early product development to post-approval lifecycle management, we provide expert Regulatory Affairs (RA) support tailored to your organisation and product portfolio. Whether you require strategic regulatory guidance, dossier preparation and submissions, regulatory maintenance, or support with medical devices and MDR compliance, our specialists help you navigate complex regulatory requirements, identify potential challenges early, and achieve efficient market access while maintaining compliance throughout the product lifecycle.
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Regulatory Affairs throughout the product lifecycle
Whether you are applying for a new Marketing Authorisation or maintaining an existing one, regulatory affairs is essential to ensure your medicinal product remains compliant throughout its lifecycle.
Before submitting a new Marketing Authorisation Application, a robust regulatory strategy and compliant dossier are required. This may include, among other activities, regulatory gap assessments, dossier preparation and review (eCTD/CTD), publishing and submission support, regulatory strategy development, CMC documentation, lifecycle planning, and interactions with health authorities.
However, regulatory affairs does not end once the Marketing Authorisation is granted. Throughout the lifecycle of your medicinal product, regulatory requirements continue to evolve and must be actively managed. This may include variation management, renewals, line extensions, responses to health authority questions, maintenance of product information, artwork and labeling reviews, regulatory intelligence, dossier updates, market expansion activities, and ongoing compliance with EU and local regulatory requirements.
Our Regulatory Affairs experts provide practical and tailored support, helping you navigate complex regulatory requirements and ensuring your products remain compliant from development through commercialization.
Our Regulatory Services
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We provide strategic regulatory guidance throughout the product lifecycle, helping you navigate complex EU legislation and develop efficient pathways to market.
Services include:
- Regulatory strategy and EU legislation advice
- Regulatory pathway assessments
- Scientific advice applications
- Change of legal status (Rx to OTC and other classifications)
- Regulatory planning for product development and lifecycle management
Whether you require strategic regulatory guidance for a single project or comprehensive support throughout your product's lifecycle, we provide the expertise and regulatory insight needed to achieve efficient market access and maintain compliance.
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Our specialists prepare, review, submit, and maintain high-quality regulatory dossiers to support successful registrations across Europe.
Services include:
- Regulatory dossier preparation and submission
- National, MRP, DCP, and centralized procedures
- eCTD compilation, publishing, and lifecycle management
- Dossier gap analyses and regulatory assessments
- Submission strategy and regulatory correspondence
Whether you need support with a single submission, dossier remediation, or complete dossier lifecycle management, we provide the expertise and reliability required to deliver compliant and successful regulatory submissions.
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We ensure that product information is accurate, compliant, and clearly communicated to healthcare professionals, patients, and regulatory authorities.
Services include:
- Preparation and maintenance of SmPCs
- Package leaflets (PILs)
- Product labelling and artwork review
- Readability testing and user consultation studies
- Regulatory reviews and updates of product information
Whether you require the development of new product information materials or ongoing maintenance of existing documentation, we provide the expertise needed to ensure regulatory compliance and clear communication for users.
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We support manufacturers in achieving and maintaining compliance with the Medical Device Regulation (MDR), from regulatory strategy to market access.
Services include:
- MDR compliance support
- Device classification and regulatory strategy
- Technical documentation review and compilation
- CE marking support
- Conformity assessment preparation
- Outsourced PRRC services
Whether you require a fully outsourced PRRC function, support with MDR compliance, or guidance through the CE marking process, we provide the expertise and continuity needed to successfully place and maintain medical devices on the European market.
Expertise you can rely on
Meet our Regulatory Affairs Team
At Interdos, our strength lies in the expertise and experience of our people. Our Regulatory Affairs team consists of experienced professionals with in-depth knowledge of EU and local regulatory requirements, providing practical and strategic support throughout the medicinal product lifecycle.
We believe that successful collaboration starts with understanding your organisation, your products and your specific regulatory needs. That is why we work closely with our clients, combining regulatory expertise with a pragmatic and solution-oriented approach.
Whether you need support with a specific regulatory activity, additional expertise for your team or long-term outsourced Regulatory Affairs support, you will work directly with experienced professionals who understand both regulatory requirements and the practical challenges of day-to-day Regulatory Affairs.
From regulatory strategy and submissions to lifecycle management and ongoing regulatory compliance, our team helps you navigate requirements efficiently and keep your products on the right regulatory path.
Meet our Regulatory Affairs team and discover the expertise behind our RA services.
Looking for Regulatory Affairs support?
Contact us!
Whether you need support with a specific RA activity, want to strengthen your Regulatory Affairs system or are looking for an experienced partner for ongoing support, we are happy to discuss your needs.
Get in touch with our Regulatory Affairs Team to explore how we can support your organisation.
