NUVO Consultancy - Pharma & Regulatory Consultant

08/12/2022

NUVO Consultancy
Hiring Alert-Office Admin
Experience : 0 - 6 months, Managing Office, Accounts, social media etc..
Qualification: BA/BCom
Time : 9 Am to 6pm, Monday to Friday
Location : LBS Marg, Nahur (W), Mumbai
Kindly send CV to info@nuvoconsultancy.com
www.nuvoconsultancy.com

30/07/2021

Good Manufacturing Practice (GMP)-
- NUVO Consultancy offers various GxP services like GMP Audits, computer system validation.
- Pre-inspection audits for WHO, USFDA, EU, ANVISA, TGA and all other health authorities.
- Health authority inspection Compliance and support, Implementing and monitoring the Quality Management system (QMS).
- Vendor Audits for Formulation, API, Intermediates, Excipients, Raw materials, packaging material.
- Computer system validation (CSV), ex*****on & compliance
- Routine GMP audits & compliances
- GAP assessment audit services
- Data Integrity compliance and Supporting Document s Auditing
- Inspection Readiness / Pre-Approval GMP Inspection Audits
- GMP Quality Systems improvement As per ICH Q8;Q9;Q10 (PQS)
- Serving for your External audit observations compliance and Monitor the CAPA
- Qualification and cleaning validation as per latest ADE/PPE concept
- Bioequivalence studies monitoring and CRO /study audits
#

29/07/2021

NUVO Consultancy offers eCTD publishing services
- eCTD Compilation, QC Review, Technical Validation and Submission Hosting
- eCTD Lifecycle Management
- Baseline eCTD : Dossier conversion from Paper/CTD/NeeS to eCTD.
- Importing and Cloning of Existing eCTD Applications
- US FDA: ANDA Dossiers 505j, 505(b)(2), CBE0, CBE30, PAS, API DMF Type-II, Type-IV-Excipient DMF, Type -III Packaging, Amendments, Annual updates, query responses etc…
- EU: MAA Dossiers for National/DCP/MRP, ASMF, CEP, Query responses, Renewals, variations etc…
- GCC: Baseline publishing, New Dossiers, Query responses, Renewals, variations etc…
- Health Canada, AU-TGA, MCC-ZA, Thailand (ASEAN), ROW: Dossiers, DMF, Query responses, Renewals, variations etc…
- Pdf publishing: PDF - Ready for Submission, Bookmarking, Hyperlinking,
- OCR (Optical Character Recognition), Embed Fonts, Compliant with Regulatory Requirements

28/07/2021

NUVO Consultancy offers CTD Dossier writing, review, publishing & submission services for global markets like US FDA, EU, 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

US Submissions:
Dossiers for ANDA 505j, 5050b(2), CBE0, CBE30, PAS, to US FDA, EU MAA via DCP, MRP, RU MRP, National, CTD Dossier, ACTD for ASEAN
Dossier Gap analysis
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 and many more

EU submissions :
Dossier writing, review and submission filing for EU-MAA for MRP, DCP, National fillings and Running the DCP, MRP and RU MRP procedure until approval along with national filing.
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.

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.

27/07/2021

DMF Submissions:

DMF Gap Analysis
DMF preparation from writing to publishing to submission to global health authority.
DMF writing, filing and eCTD Publishing for :
US-Type –II DMF - API, Type-III - Packaging material, Type-IV - Excipient
EU- ASMF and CEP (Applicants Part & Restricted Part), Open & Close part,
WHO DMF, China-DMF, Japanese DMF, CTD DMF for all countries
eCTD conversions: DMF original, filings annual updates, changes etc
DMF and CEP submission via electronic portals to EU, USA and WHO
Excipient DMF Writing and consultation
Packaging material DMF writing and consultation

Online Electronic Submission Gateways :
- Europe – CESP
- USA FDA – ESG
- Additions in progress.
eCTD Publishing :
- eCTD Compilation, QC Review, Technical Validation and Submission Hosting
- eCTD Lifecycle Management
- Baseline eCTD : Dossier conversion from Paper/CTD/NeeS to eCTD.
- Importing and Cloning of Existing eCTD Applications
- US FDA: ANDA Dossiers 505j, 505(b)(2), CBE0, CBE30, PAS, API DMF Type-II, Type-IV-Excipient DMF,
Type -III Packaging, Amendments, Annual updates, query responses etc…
- EU: MAA Dossiers for National/DCP/MRP, ASMF, CEP, Query responses, Renewals, variations etc…
- GCC: Baseline publishing, New Dossiers, Query responses, Renewals, variations etc…
- Health Canada, AU-TGA, MCC-ZA, Thailand (ASEAN), ROW: Dossiers, DMF, Query responses,
Renewals, variations etc…
- Pdf publishing: PDF - Ready for Submission, Bookmarking, Hyperlinking,
- OCR (Optical Character Recognition), Embed Fonts, Compliant with Regulatory Requirements

29/06/2021

We are proud to share that NUVO Consultancy has completed 9 years of service to Global Pharma industry. During our journey we have served more than 600 projects for Regulatory, GXP, Development etc...and have been part of success journey of many Pharma companies across the globe. We want to thank all our customers who believed and trusted us.
Thank you for blessing us with your warm wishes and appreciation during our anniversary month, they are very special to us. We look forward to continue our journey of serving Pharma industry and enabling customer success.

Stay Safe!
Thanks & Best Regards
Pooja Telavane
Founder and Chief Regulatory Consultant
Mumbai | India
📞: +91-9819253992
📧: info@nuvoconsultancy.com
URL: www.nuvoconsultancy.com

03/05/2021

Dossier Services-
NUVO Consultancy offers CTD Dossier writing, review, publishing & submission services for global markets like US FDA, EU, 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

US Submissions:
Dossiers for ANDA 505j, 5050b(2), CBE0, CBE30, PAS, to US FDA, EU MAA via DCP, MRP, RU MRP, National, CTD Dossier, ACTD for ASEAN
Dossier Gap analysis
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 and many more

EU submissions :
Dossier writing, review and submission filing for EU-MAA for MRP, DCP, National fillings and Running the DCP, MRP and RU MRP procedure until approval along with national filing
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

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.

01/05/2021

eCTD Publishing-

NUVO Consultancy offers eCTD publishing services
- eCTD Compilation, QC Review, Technical Validation and Submission Hosting
- eCTD Lifecycle Management
- Baseline eCTD : Dossier conversion from Paper/CTD/NeeS to eCTD.
- Importing and Cloning of Existing eCTD Applications
- US FDA: ANDA Dossiers 505j, 505(b)(2), CBE0, CBE30, PAS, API DMF Type-II, Type-IV-Excipient DMF, Type -III Packaging, Amendments, Annual updates, query responses etc…
- EU: MAA Dossiers for National/DCP/MRP, ASMF, CEP, Query responses, Renewals, variations etc…
- GCC: Baseline publishing, New Dossiers, Query responses, Renewals, variations etc…
- Health Canada, AU-TGA, MCC-ZA, Thailand (ASEAN), ROW: Dossiers, DMF, Query responses, Renewals, variations etc…
- Pdf publishing: PDF - Ready for Submission, Bookmarking, Hyperlinking,
- OCR (Optical Character Recognition), Embed Fonts, Compliant with Regulatory Requirements

22/04/2021

DMF Submissions:

DMF Gap Analysis
DMF preparation from writing to publishing to submission to global health authority.
DMF writing, filing and eCTD Publishing for :
US-Type –II DMF - API, Type-III - Packaging material, Type-IV - Excipient
EU- ASMF and CEP (Applicants Part & Restricted Part), Open & Close part,
WHO DMF, China-DMF, Japanese DMF, CTD DMF for all countries
eCTD conversions: DMF original, filings annual updates, changes etc
DMF and CEP submission via electronic portals to EU, USA and WHO
Excipient DMF Writing and consultation
Packaging material DMF writing and consultation

17/08/2020

Visit us at www.nuvoconsultancy.com for our services information for Pharm industry and Global Regulatory support

Pharmaceutical Regulatory &Project Management Consultants