URRA CMC

We provide tailored regulatory affairs and CMC services to streamline drug approval processes, ensuring compliance and efficiency to bring safe and effective medications to market faster. The Pharmaceutical World is highly regulated in order to provide patients with the most safe, efficient and of excellent quality pharmaceutical products. As part of these regulations, it is a legal matter of a pharmaceutical company to monitor updated guidance and to incorporate them into their day-to-day practice, utmost in their applications. Failure to comply to existing regulations may be highly damaging to a company in terms reaching out to their patients, perceived image as well as from a financial prospective. To solve this, URRA CMC constitutes a web-based, simple, and cost-effective solution to gather necessary knowledge on building quality dossiers for medicinal products, whether in clinical or commercial phase. We also provide CEO, CSO and decision-makers with consultancy services for any CMC-related question on clinical (CTA, IND, IMPD) or marketing application (BLA, MAA, NDA) submissions, based on our 15+ years of expertise on the subject.