Regulatory Affairs & Pharmacovigilance

ITALMED gives paramount importance to the regulatory affairs which play a critical role in placing and maintaining medicinal products, medical devices, and food supplements in the market, under the national legislation and the European Union's regulatory requirements. This department is responsible to forward all the scientific documentation in terms of quality, safety, and efficacy to the National Regulatory Authority, in order to obtain (renew) the Marketing Authorization for products to be eligible to seek the market. Other important regulatory activities are the review of PILs and SPCs of medicinal products based on the approved variations and all variations that affect the quality, safety, and the efficacy of the products. Through the regulatory affairs department, Italmed has achieved to establish a sturdy bridge of collaboration and trust between the national regulatory authority and the MA holders.

Monitor Dynamic Changes in Regulation

Our expert regulatory team is well-aware of both national and international legislation, guidelines, and customer practices. We also keep ourselves updated with the dynamic changes of the government rules and regulations regarding drug regulations. We also monitor the time-to-time update of the company’s product so that the labeling and distribution match the regulatory means. Being present in our markets for a long time now and also having established ourselves as leaders in our field, we have managed to create friendly contacts with our national regulators and also gain extensive know-how expertise on being able to successfully navigate past potential challenges that may arise when it comes to regulatory affairs.

Formulate Regulatory Strategy

ITALMED believes in strategic distribution, thus prepare the regulatory strategy for all regulatory submission keeping in mind the smallest aspects of the projects. Whether the project is international or domestic, we make sure our contract works profiting for both sides.

Regulatory Consultation

We are always there for regulatory advice and consultation. We ensure a quick response to any queries or problems regarding drug approval.

Pharmacovigilance

Since one of our key priorities is the safety of patients, the pharmacovigilance office at Italmed is alert and available 24h/24h, 7d/7d for any concern that might affect the quality, safety, and/or efficacy of products. Working closely with the national regulatory authority and the EU/QPPV, we have built a pharmacovigilance system that complies with national and European regulatory requirements.

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