Dossier services :

NUVO Consultancy offers CTD Dossier writing, review, publishing & submission services for global markets like US FDA-ANDA, EU-MAA, ROW markets.
– Full support in preparation of CTD Module
Module 1 – Administration
Module 2 – Quality summary, Clinical and Nonclinical overview and summaries
Module 3 – Quality
Module 4 – Non-clinical
Module 5 – Clinical
– Product information preparation & update (SmPC, PIL and Labeling).
– Dossier conversion from paper to CTD to ECTD
– Dossier due diligence and gap analysis

USFDA submissions :

Dossier writing, review and filing of ANDA 505j, 5050b(2), CBE0, CBE30, PAS, to US FDA.
DMF writing, review and filing for DMF for Type – II API, Type-III Packaging, Type IV-Excipients with their Life cycle management of Annual reports, amendments.
US FDA submission via online portal ESG
SPL preparation for US FDA
US DMF agent and listing agent
US listing agent services:
– Establishment registration (ER)
– Labelor code Application
– NDC and Drug listing
– Annual update for ER
– Annual Listing Certification for eDRLS
– GDUFA cover Sheet filing

EU submissions :

Dossier writing, review and filing for EU-MAA for MRP, DCP, National fillings.
Running the MRP and DCP procedure until approval.
MAA submission via online portal CESP
Slot applications with health agencies for submissions.

ROW Submissions:

Dossier conversion form National format to CTD.
ROW-Dossier : Country specific formats, CTD, ASEAN CTD
eCTD conversions: DMF and Dossiers for applicable ROW countries.

CTD Clinical and non clinical overview and summaries modules 2.4, 2.5, 2.6 and 2.7 report writing for EU And ROW submission.

Online Electronic Submission Gateways :
– Europe – CESP
– USA FDA – ESG
– Additions in progress.

Indian DCGI Submission : Generics, Cosmetics, Medical devices & Biologics
– New Drug Approvals
– FDC Approvals
– Import & Registration
– Global Clinical Trials
– BA/BE NOC
– Post Approvals
– Cosmetics Import Registration
– Embassy Attestation
– Nutraceuticals/Food Supplements Approval – FSSAI
– Ethics Committee Registration

Life-cycle management : Changes to the US ADA – CBE0, CBE30, PAS, US DMF- Amendments, Annual reports, Annual updates, variation Type IA, Type IAIN, Type IB, Type II filing, ASMF Renewals, CEP updates and renewals, CTD DMF.