Looking to simplify the market launch of medical devices, food supplements, and cosmetics? With Gruppo FarmaImpresa, it’s possible
Having an innovative idea or a high-quality product is not enough for medical devices, food supplements, or cosmetics. To successfully reach the market, companies must navigate a complex and highly regulated path.
In Europe, this process revolves around key elements such as the preparation of a technical dossier, obtaining CE marking (for medical devices), assessment by a notified body, and submission to the competent authorities.
Developing a technical dossier from scratch is far from simple: it requires time, expertise, and significant management costs. That’s why partnering with an experienced manufacturer like Gruppo FarmaImpresa, based in Italy, makes all the difference. Gruppo FarmaImpresa not only develops its products in-house, but also owns all the necessary dossiers for immediate market access.
Gruppo FarmaImpresa is the ideal partner for those seeking quick access to products that are fully compliant with European regulations and backed by clinical data proving their effectiveness.
Let’s explore how the process works—and why choosing a manufacturer with ready-to-use dossiers and clinical validation can be a true competitive advantage.
How much does it cost—and how long does it take—to develop a dossier from scratch?
If a company wants to develop a new medical device, food supplement, or cosmetic internally, it must go through several complex phases:
- Development phase: This includes clinical data collection, lab testing, stability studies, and validations. For example, a medical device can take 12 to 18 months to fully develop.
- Specialized team: You’ll need highly qualified professionals such as biomedical engineers, regulatory experts, clinicians, chemists, and project managers to ensure proper project management.
- Management costs: Beyond the core team, there are additional costs, including any updates or integrations required by the notified body, which checks that the product meets all regulatory requirements.
The technical dossier must also comply with specific EU regulations:
- Regulation (EU) 2017/745 for medical devices
- Regulation (EU) 1223/2009 for cosmetics
- Regulation (EU) 1169/2011 for food supplements
For medical devices, once the dossier is complete, it may need to be evaluated by a notified body, which assesses safety and performance before granting CE marking.
All of this demands significant time, investment, and risk.
Gruppo FarmaImpresa: Your Fast Track to Market
Gruppo FarmaImpresa eliminates this complexity by offering fast and efficient solutions.
As both manufacturer and owner of all product dossiers, Gruppo FarmaImpresa allows its clients to:
- Access already developed and certified products, ready for commercialization
- License products without undergoing lengthy development processes
- Enter the market simply by applying their brand or packaging
This way, companies can save months of delays, cut development costs, and offer their clients products that are already tested, compliant, and clinically validated.
The Value of a Ready-to-Use Technical Dossier
The technical dossier is not just a formality—it’s the heart of product compliance.
It includes detailed information on:
- Technical specifications
- Safety data
- Clinical evidence
- Manufacturing processes
- Post-marketing surveillance strategies
Having a complete dossier means you can immediately launch the product without additional verifications or regulatory delays.
A Simplified Procedure with Gruppo FarmaImpresa
Thanks to Gruppo FarmaImpresa’s expertise, the route to market is reduced to just a few simple steps:
- Choose the product that fits your target market
- Customize the branding or packaging (if needed)
- Sign the supply and dossier licensing agreement
- Quickly register the product with local authorities (if required)
- Launch and sell immediately
Why Choose Gruppo FarmaImpresa?
Choosing Gruppo FarmaImpresa means choosing:
- Fast market access
- Guaranteed compliance with EU regulations
- Drastically reduced development costs
- Ongoing regulatory support
- Flexible, customizable solutions
As a manufacturer of medical devices, food supplements, and cosmetics, we’re the perfect partner for companies aiming to grow quickly and offer effective, certified products with full support.
