Gruppo FarmaImpresa: Scientific Evidence and Clinical Trials
Our Commitment: Product Science, Safety, and Efficacy
At Gruppo FarmaImpresa, our mission is to guarantee effective and safe products, supported by a solid scientific foundation. To achieve this, we design and conduct rigorous clinical trials on food supplements, cosmetics, and substance-based medical devices. Our commitment extends to full compliance with the most stringent regulations, such as the European Medical Device Regulation 2017/745 (MDR).
We also continuously collect post-market surveillance data to monitor and consistently ensure the safety of our products.
Thanks to our extensive in-house experience and deep cross-sectoral expertise, we can manage and conduct comprehensive clinical studies. This allows us to collaborate effectively with all key stakeholders: from participants to ethics committees, from competent authorities to scientific and academic societies.
Our approach is guided by continuous updates on increasingly stringent international regulations and guidelines, ensuring the highest levels of compliance and quality.
Below, we present some of the clinical trials that attest to the efficacy and safety of our products:
Clinical Study for Infant Colic
The clinical study of Rilefast CE, a medical device based on simethicone and silicon dioxide, showed a significant reduction in infant colic symptoms. Treated infants experienced less pain and crying, with particularly positive results in cases of increased initial distress.
Rilefast CE and infant colic: ultrasound analysis of intestinal gas
This study is a supplement to research on the efficacy of the medical device Rilefast CE based on simethicone and silicon dioxide in the treatment of infant colic, evaluating the results by ultrasound examination to measure intestinal gas content.
Study on the efficacy of Simeticone in water in the treatment of gastrointestinal disorders in infants
The clinical study on comil oral drops, a medical device based on Simeticone in water, demonstrated a significant reduction in gastrointestinal symptoms in infants. After two weeks of treatment, a marked improvement in abdominal pain, bloating and aerophagia was observed, with a positive impact on the quality of life of the young patients.