Regulatory Affairs
Navigating compliance with clarity, precision, and confidence. At CORONIS Research, our Regulatory Affairs department supports your clinical and product development programs across all stages — from study start-up and clinical trial submissions to product registration and post-authorization activities. With more than two decades of experience, our regulatory experts have a deep understanding of the European and national regulatory environments, enabling effective communication with Competent Authorities and Ethics Committees and the timely achievement of your project goals. We provide strategic guidance and hands-on support to help you plan, compile, and submit documentation that meets every regulatory requirement. Our goal is to streamline the approval process, minimize risk, and ensure your innovations reach the market efficiently and compliantly.
Our Core Regulatory Affairs Services
Regulatory Consulting & Compliance
Expert guidance through every stage of regulatory planning and execution.
Our team provides regulatory consulting and compliance support from the earliest concept discussions to post-marketing activities.
We help sponsors interpret evolving requirements, design regulatory roadmaps, and prepare compliant submission packages.
Services include strategic advice, gap assessments, compliance audits, and ongoing support for clinical and marketing applications.
Regulatory Insights & Strategy
Developing smart, forward-looking regulatory strategies tailored to your product.
CORONIS develops customized regulatory strategies that align with your product’s scientific, commercial, and geographical goals.
We analyze the current landscape, anticipate potential challenges, and propose the most efficient regulatory pathways for authorization.
Our continuous tracking of legislation and regulatory trends ensures that your strategy remains current, agile, and competitive.
Marketing Authorization Applications & Maintenance
Comprehensive support from submission to post-approval lifecycle management.
We manage the preparation, compilation, and submission of Marketing Authorization Applications (MAAs) and handle subsequent variations, renewals, and extensions.
Our regulatory specialists prepare complete technical documentation, coordinate responses to authority queries, and ensure ongoing compliance throughout the product lifecycle.
Services cover prescription medicines, essential similar products, medical devices, over-the-counter products, and food supplements.
Market Access & Pricing
Bringing your product successfully from approval to availability.
Beyond authorization, CORONIS assists with Market Access and Pricing processes, providing insight into reimbursement frameworks and value demonstration.
We help sponsors prepare submissions for pricing and reimbursement applications, ensuring alignment with national health authority requirements and optimizing time-to-market.
Market Research & Analysis
Understanding the market to strengthen every clinical and commercial decision.
At CORONIS Research, we view market research as an essential part of the product development lifecycle — not a post-launch activity.
Our Market Research & Analysis services provide evidence-based insights that guide early decision-making, from discovery to late-phase development and commercialization.
With over 15 years of experience, our experts conduct in-depth analyses to evaluate market potential, patient population dynamics, competitive landscape, and reimbursement environments.
This approach is particularly valuable for rare disease and orphan therapies, where accurate data and economic modeling are crucial to defining therapeutic positioning and value early on.
We help sponsors assess whether a product’s clinical attributes and health-economic impact can ensure a successful launch and sustained market access, providing strategic recommendations tailored to local and regional contexts.
Promotional Materials Compliance
Ensuring scientific accuracy and adherence to ethical communication standards.
Our experts review and approve promotional and educational materials to confirm compliance with applicable advertising and promotional guidelines.
We ensure all content is accurate, balanced, and consistent with approved product information, supporting responsible and transparent communication with healthcare professionals and the public.
Medical Devices & In-Vitro Diagnostics
Regulatory support throughout the device and diagnostic lifecycle.
CORONIS provides regulatory consulting for medical devices and in-vitro diagnostics, assisting with technical documentation, conformity assessment, and authority interactions.
We help sponsors meet European and national requirements for registration, labeling, clinical evaluation, and post-market surveillance — ensuring smooth and compliant product launch and maintenance.
Food Supplements & FSMPs
Expert guidance for compliant development and marketing of nutrition products.
Our regulatory team supports the notification, labeling, and safety documentation for food supplements and foods for special medical purposes (FSMPs).
We assist in ingredient assessments, claims validation, and preparation of technical files to facilitate market entry and ongoing compliance.
Biocides, Detergents & Cosmetics
Tailored support for regulatory submissions and product safety compliance.
CORONIS offers regulatory services for biocides, detergents, and cosmetics, ensuring products meet current European safety and notification standards.
We prepare registration documentation, manage product dossiers, and oversee safety reporting processes — maintaining compliance while protecting product integrity and consumer confidence.