I just wanted to share a quick note and let you know that you did a really good job in helping us in regulatory services. I am glad to say that we decided to work with Nuvo . We never had any problem at all and all our registrations and renewals were approved with no or minimal queries.
NUVO Consultancy was conceptualized in 2012 by the Regulatory Professional and Educator Mrs Pooja Telavane, who have been associated with some of the known pharmaceutical companies for close to two decades now.
At NUVO, we offer our clients highly professional and effective services to all of their Pharma and Regulatory requirements. We also provide expert procedural and technical guidance to our clients so as to manage complex regulatory procedures efficiently. We provide service for eCTD publishing and submissions and other special requirements.
We support our customers, with the complete project management solutions which includes but not limited to Regulatory filings and solutions, Life cycle management, GMP compliance, IT Solutions for Pharmaceutical industry, Green field projects, Turnkey projects, Business development, Product development and analytical solutions and services, Genotoxicity study with the software, Clinical and Bioequivalence studies, , Pharmacovigilance (PV support).
NUVO has rich and extensive experience in managing regulatory submissions and procedures. NUVO deliver quality module preparation and submission with eCTD Publishing of DMF, CEP for EDQM via CESP, ANDA 505j & 505b(1)(2), European filings via regulatory procedures like DCP, MRP, National procedures, WHO prequalification, China filings and other CTD filings across the globe. Apart from managing submissions, the team has profound expertise in but not limited to devising regulatory strategies, module writing for DMF and Dossiers, Life cycle management, GMP audits, Trainings, It solutions for Healthcare and pharmaceutical industry and Pharma support services with project management as described above.
NUVO always aspire to provide an efficient and value added support in obtaining faster Approvals for our clients. NUVO has submissions accounts with US FDA’s ESG and Europe centralized submission portal CESP. We operate on cloud based system and data security is the top priority.
We also act as a country representative, drug listings Agents for many regions like USA, EU, India and many.