Regulatory Services

V-Nano outclasses competitors for its equipment, processes and manufacturing, all in compliance with current good manufacturing practices (cGMP); yet we recognize that all of this, without proper and solid documentation, is not striving for excellence. This is why, at V-Nano we chose to strategically partner with highly skilled professionals, best-in-class for investigational medicinal product dossier (IMPD) writing, for chemistry, manufacturing and controls (CMC) filing, as well as for producing a comprehensive range of additional documentation; this reduces time to market of your orphan disease or specialty drug product.

As to maximize approval rates, V-Nano’s experienced team works with you to elaborate your IMPD filing strategy; in addition to formulation and quality assurance, V-Nano is your partner of choice for CMC compliance.

Finally, after successful completion of clinical trials, we support you with your submission for commercial registration.

At V-Nano, we accompany you in every step!