Regulatory affairs services

Regulatory affairs services
Product Description

 Regulatory affairs: Dossier compilation CTD,ACTD,Nees,e CTD- Format-DMF, CEP, ASMF, IND, NDA, ANDA, BLA, MAA,505(b)(2), Paper submission, old product dossier conversion for any Dosage Form and Application Regulatory Operation: Type. Global CTD Conversion/publishing-Document Level, Submission and Report Level publishing. Structure Product labelling and DMF submission. Other Regulatory: ESG/CESP portal setup, DUNS and FEI Number, GDUFA Self identifications, Annual Establishment Registration and NDC Code. US Agent: Contact point between the FDA and company manufacturing sites and communicate with FDA for all regulatory issues/questions and follow up status on pending and approved applications. 
Quality Compliance: GAP Analysis and Improving support for all departments: Operations, Engineering, Regulatory, Reseach a...

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WORLDWIDE-COMPLIANCE

  • IN
  • 2023
    On CPHI since
  • 4
    Certificates
  • 1 - 24
    Employees
Company types
Consultancy
Primary activities
Other
Regulatory Affairs
View company profile
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Specifications
  • Details
    REGULATORY SERVICESREGULATORY AFFAIRS CONSULTING Dossier Preparation and compilation of CTD, ACTD, Nees, e CTD Format, DMF, CEP, ASMF, IND, ANDA, BLA, MAA & Medical Devices for any Dosage Form and Application type.
    OPERATIONS: eCTD Conversion and publishing.
    US AGENT Communication with FDA Supporting companies for scheduling facility inspections of Bulk Drug (Active Pharmaceutical Ingredients i.e. Drug substance and pharmaceuticals formulation i.e. Drug product manufacturing facilities, DMF query/responses communications.
    OTHER SERVICES Electronic Submission Gateway Setup for US, Health Canada, and European countries, Duns and Breath (DUNS), Facility identify the number (FEI), NDC code, Annual Establishment registration etc.
    MEDICAL WRITING/PHARMACOVIGILANCESOPs, Database, literature, Drug Safety/ICSRs, Clinical summary. To Heath authorities.
  • Selling Points
    Quality Service; GLOBAL HEALTH AUTHORITIES SERVICESUS FDA Regulatory: -

    Abbreviated New Drug Application (ANDA) Submissions Drug Master File (DMF) Submissions as per GDUFA guidelines NDA 505 b (1) and 505 b (2) Investigational New Drug (IND) Applications Self Identification, Establishment registration, Product listing. 

    Health Canada Regulatory: -

    Abbreviated New Drug Submission (ANDS)New Drug Submission (NDS) for Canada Drug Master File (DMF) Submissions

    European Drug Quality Management System (EDQM): -
    Active Substance Master File (ASMF) Submissions EU Marketing Authorization Application (MAA)Certification of Suitability (CEP) Submissions Decentralized Procedure (DCP)Mutual Recognition Procedure (MRP)National Procedure (NP)Centralized Procedure.
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WORLDWIDE-COMPLIANCE

  • IN
  • 2023
    On CPHI since
  • 4
    Certificates
  • 1 - 24
    Employees
Company types
Consultancy
Primary activities
Other
Regulatory Affairs
View company profile

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