Services
Regulatory Compliance Services

Regulatory compliance deals with the set of guidelines that an organization is required to follow in accordance with the Law. Ensuring that Your products meet all applicable regulatory requirements for commerce and advertising activities is an increasingly complex and critical effort.

BLYMUM has an excellent knowledge of Italian, EU and international legislation to be respected for safe and legal dealing concerning food supplements, functional foods, novel foods, nutraceuticals, cosmetics and medical devices. We deliver regulatory support throughout the whole above-mentioned products lifecycle; we update, vary and renew the above mentioned classes of products. National and European registration and maintenance procedures are available as well as due diligence activities and licensing support.

Furthermore, we provide regulatory compliance services for the above-mentioned product classes, integrated with three specific business practices:

Intellectual Property Management

We assist You in studying, drafting and deposit of applications for Italian, European or PCT international patents at the Italian Office for Patents and Trademarks, the European Patent Office and the World Intellectual Property Organization. Along with dossier filing and technical assistance, regulatory compliance support is given.

Bid Management

Bids are first and foremost business documents. Knowing how to develop bids efficiently and communicate them powerfully is a key business skill, essential for market success and growth. We support You along with Your typical bidding activities, through an integrated approach based upon regulatory compliance monitoring, agile project management, design thinking and innovative communication, delivering a recognized added value to Your strategic commercial projects.

Marketing and Communication

Marketing is a process through which a company or institution determines the most suitable development on the reference market, for achieving their objectives. Within the healthcare/wellbeing sector, this structured process is substantially conditioned by legislation.
We provide a complete support both for marketing planning and regulatory compliance activities, aiming at delivering creative and consistent plans whose contents and communication/ execution channels are compliant with the applicable laws. 

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POSTS
31/01/2023
Regolamento (EU) n. 536/2014 sulle sperimentazioni cliniche
Dopo il periodo di transizione, dalla data odierna 31 gennaio 2023 tutte le procedure di autorizzazione della sperimentazione clinica devono obbligatoriamente essere richieste segu...
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22/11/2022
Market Surveillance of Medical Devices
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