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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…Read More
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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…Read More -
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, J…Read More -
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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).
-…Read More -
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).
-…Read More
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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 – N…Read More -
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NUVO offers eCTD Publishing for global submission, CEP, ASMF, CTD DMF, API US DMF Type-II, Type-IV-Excipient DMF, Type -III Packaging, Dossiers – EU MAA, ROW, US ANDA, 505j, 505(b)(2), Life cycle management, Variations, CBE0, CBE30, PAS, Amendment, Annual updates, query responses
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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…Read More -
Hello everyone,
Lyomark Pharma (
), a German company based in Munich, is searching for In-licensing partners worldwide for our portfolio:– Alveofact (surfactant)
– Neofact (medical device for surfactant administration)
– Vancomycin
– Somatostatin
– OctreotidLooking forward to hearing from you.
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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, J…Read More
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NUVO Consultancy is one point Pharma Regulatory and Project Management resource, servicing the ever growing requirements of the Pharma Industry. We offer efficient and reliable regulatory and quality support, focused especially from the perspective of international market requirements.
We provide creative, flexible, dedicated and reliable…Read More
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Excipient: Salcaprozate sodium(CAS:203787-91-1) and its intermediate 8-Octanoic Acid (CAS:183990-46-7). Welcome to contact us via meng@yueweichemical.com
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Polyquaternium-1(CAS No.：75345-27-6) 95% solid in stock,welcome to contact us. meng@yueweichemical.com
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Dears,
I am looking for a CMO for a sterile Nasal Spray product. Could you please contact me if you provide such service? -
Dear All,
May I ask for your help in sourcing synthetic lactose-monohydrate with USP confomity?
Thank you in advance.
1 Comment -
Jinan Huashihang Chemical Co., Ltd provide Gatifloxacin、Moxifloxacin Hydrochloride intermediates
Quinoline carboxylic acid
112811-72-01-cyclopropyl-6,7-difluoro-1,4-dihydro-8-methoxy-4-oxo-3-quinoline carboxylic acid ethyl ester
112811-71-9
wecome to contact with u…Read More liked this
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Debleed can help stop superficial bleeding, helps relieve pain and can prevent infection. It disinfects the wound, protects the skin around the cut or scrape and promotes natural healing of the damaged tissues.
It can rapidly absorb the blood from minor scrapes and cuts to form a soft layer over the area that helps stop bleeding fast.
This…Read More - Load More Posts
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