Clear and robust approach to the management of submissions is essential in order to ensure that your data are presented appropriately and aligned to the needs of regulators. Before submitting your dossier to the relevant authority, you need to safeguard your investment by ensuring you have considered all the key application criteria. Only once this process has been completed, are you in a position to submit your application for approval.
How can we help?
Our expertise allows us to support clients through the entire product lifecycle. We understand that getting it right first time is an important part of the process and this is something at which we excel. From the initial planning stage and organising a pre-submission meeting to obtain procedural, regulatory and legal advice, to gearing the submission for the Centralised, Decentralised or Mutual Recognition Procedure and advising on the scientific disciplines required for a marketing authorisation application (MAA) – we have the necessary qualifications and experience. We can publish and manage submissions at every stage of the process and across all spectrums, including paper, non-eCTD electronic submissions (NeeS), to eCTD, MAAs, Clinical Trial Authorisations (CTAs), Clinical Study Reports (CSR)and periodic safety update reports (PSURs) – ensuring that your submission is compliant with the individual requirements of the receiving regulatory authorities.
For a more detailed discussion on how we can help you, contact us on +91 886000 9879 or email us via our contact form