Regulatory Services
Regulatory Services
Regulatory Advice at Every Stage
Regulatory issues play a very important role in our business and requires specialized knowledge and precision. Our highly skilled Quality & Regulatory Affairs experts ensures that all our food supplements, cosmetics, medical devices and pharmaceuticals comply with relevant regulations at every stage of their lifecycle. Backed by decades of experience, we navigate regulations and standards with confidence.
We provide comprehensive support for all your regulatory needs, combining up-to-date knowledge with expertise in advanced scientific disciplines, technical requirements, and legal frameworks. In today’s fast-paced and competitive market, reducing time-to-market is crucial. Leveraging our regulatory expertise, we help to bring your products to market efficiently and in full compliance, ensuring a faster path to success.
Our R&D services at a glance:
- Support with questions relating to the marketability of products
- Advice for product labelling/claims
- Help with regulatory product registration
- Assistance with market placement notification
- Issuance of Certificate of Free Sale
- Regulatory services for medical devices
- Regulatory services OTC pharmaceuticals (Germany)
Specialized Expertise in OTC pharmaceuticals Regulatory Affairs
Our specialized Drug Regulatory Affairs (DRA) team not only supports our pharmaceutical clients (exclusively in Germany) with regulatory compliance, but also handles all regulatory issues regarding our own marketing authorizations (IPs) with precision and efficiency. To optimize the commercialization of pharmaceuticals, in the maximum case we ensure seamless regulatory management and market readiness by taking on the following responsibilities for:
- Acting as marketing authorization holder (in any case)
- Serving as the manufacturer (with manufacturing authorization and GMP certification) (in any case)
- Taking the role as pharmaceutical entrepreneur (optional)
Always with the legally required competent staff, of course.
You decide what role you want us to play, pharmaceuticals entrepreneur and manufacturer or only manufacturer:
- Pharmaceuticals entrepreneur with full responsibility (in the case of our own authorizations also authorization holder, alternatively co-distributor) and manufacturer, i.e. EVP takes responsibility at all stages up to the marketing of the product
- Manufacturer only (if you as a customer want to play the role of pharmaceuticals company yourself, e.g. with your own shares discussion rights).
Find out more about our responsibilities and roles in pharmaceutical distribution.
Our Services as Pharmaceuticals Entrepreneur:
- Our information officer ensures that all product labeling complies with legal requirements.
- We maintain a pharmacological vigilance system, overseen by a qualified expert -the pharmacovigilance- to monitor product safety, report and assess adverse effects, and implement risk-minimization measures as needed.
- We guarantee the product’s marketability and manage its entire life cycle.
- We guarantee that all advertising complies with the marketing authorization and the Drugs Advertising Law
- We have a reliable system for managing complaints and recalls.
- We ensure full compliance with official information and reporting obligations set by regulatory authorities.
- We maintain a comprehensive quality assurance system to support all these processes.
Our Services as Manufacturer:
- We take responsibility for the market release of your product, ensuring compliance with marketing authorizations and specifications. This includes verifying production and testing results, qualifying suppliers, maintaining GMP-compliant manufacturing processes, and addressing any deviations.
- We perform comprehensive Product Quality Reviews (PQRs) and collaborate with the license holder on follow-up studies to ensure continuous quality and compliance.
Specialized Expertise in Medical Devices Regulatory Affairs
Use our IPs for your brand
Our Group member Euro Vital Pharma (Germany) provides a comprehensive portfolio of substance-based medical devices (own Ips). With this portfolio we are a leading supplier for the biggest German retailer. You can trade our IPs as a co-distributor also outside Germany – we support you in all regulatory matters and ensure that our products comply with all relevant regulations. Accordingly, our quality management system meets the requirements of ISO 13485 for medical devices.
Our services
- As Legal Manufacturer, we fulfill our duty to the full extent according to the MDR including Quality Management System (QMS), Product Design, Risk Management System, Clinical Evaluation and an in-house Person Responsible for Regulatory Compliance (PRRC)
- Our competent team consisting of PRRC’s and Medical Device Consultants ensure that all product labeling complies with legal requirements and advise our customers on product safety, labelling and other technical issues
- We guarantee the product’s marketability and manage its entire life cycle including Post Market Surveillance
- Our reliable system for managing complaints and recalls includes the recording and reporting of incidents and a tool for field safety corrective actions
We have received an extension for the certification of our medical devices under the MDR until December 31, 2028. This guarantees an uninterrupted supply for our customers.
Navigating your MDR Challenges with us
The new Medical Device Regulation (MDR) has introduced stricter requirements on the safety and performance of medical devices, making the approval and classification processes for substance-based medical devices more difficult. This transformation presents significant challenges for manufacturers, authorized representatives, importers, and distributors, including new classification rules that may require a notified body in the conformity assessment process. But don’t worry, we are here to support you. As a trusted partner, we not only provide guidance but also act as the responsible manufacturer under MDR regulations, ensuring full compliance and taking complete responsibility for the quality and safety of your products.
Your Benefits
Your benefits from a partnership with us for the marketing of medical devices
With 25 years of experience and adaptable cooperation models, we provide a trusted solution for maintaining product marketability while meeting evolving regulatory requirements.
You keep full control over your brand by marketing and distributing products under your own name.
Euro Vital Pharma GmbH only appears on the packaging and instructions for use as required by regulations. The physical production of your products can be outsourced to one or more carefully selected contract manufacturers.
Quality assurance without your own quality management system.
With our fully certified quality management system, we take full responsibility as a manufacturer, including production monitoring and market release. This ensures that our customers comply with all MDR quality management requirements and ISO 13485 standards—without the need to establish their own system.