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   News & Events

28th Feb 2012: Sanhar is leveraged with Regional specific Regulatory Submission expertise and be able to help the customers in Multi Geographical Regulatory Submissions.

20th Feb 2012: Sanhar is an Associate Member of Indian Drug Manufacturers Association (IDMA), enabled with a gateway to reach out to more Domestic Customers now.

06th Jan 2012: Sanhar Joins hands with “Registrar Corp”, an U.S. based company to leverage its Regulatory Consulting services pertaining to the U.S. FDA Registration related Businesses.

 
 
 
 
   Regulatory Submissions (Operations & Publishing)
 

Paper based regulatory submissions are becoming obsolete and e-submissions are the upcoming trend. The eCTD submissions are most preferred format at global regulatory agencies level. SANHAR has a team of highly experienced regulatory publishers who got expertise in publishing wide variety of submissions, handling e-submission management tool and having excellent understanding of current publishing standards adopted in the industry. Our regulatory publishers can help our customers through the entire publishing processes to ensure that the regulatory submission projects are completed on time thereby meeting the submission deadline at the agency level. We do have Domain experts who have a commendable experience in understanding and interpretation of all e-submission guidelines to provide services in all stages of e-submission product life cycle (Right from creation of initial 0000 sequence, document publishing, compilation, validation, submission, until transmission to regulatory agencies for review and approval). We do have expertise in optimizing the submission processes and make the e-submission processes easier for various regulatory authorities such as: US-FDA, EMEA, HC, TGA, Swiss Medic etc., We do have expertise in generating World class quality eCTD dossiers/master files and regulatory publishing services.

 
   We offer the following services in the Regulatory Submission space.
 
 
  • Regulatory Submission support
  • Dossier/CTD/eCTD Preparation
  • Transition from Paper to eCTD Format Submissions
  • Regulatory Publishing Services
  • Document Level Publishing (Providing Navigation aids and setting PDF attributes etc.,)
  • Submission Level Publishing (Submission of Metadata, Uploading, Compilation, Hyper Linking, Validation and Generation of eCTD output)"
  • Managing eCTD dossiers across agencies such as
    • US-FDA (IND,NDA,ANDA, Amendments, DMF etc.,)
    • EU (CP/NP/DCP/MRP/Variations/ASMF)
    • EDQM (CEP), HC,
    • Swiss medic
    • TGA and RoW
  • Module 1 Compilation for EU, US-FDA, HC, Swiss medic and RoW
  • Managing the complete eCTD lifecycle right from 0000 sequence to approval.
  • SPL Publishing including all types of SPL Labeling conversions from SPL R3 to SPL R4 format
  • Transition of SPL Labels, Highlights/Non Highlights through ESG
  • NDC, ER, Drug Listing
  • Setting up ESG, Digital IDs
 
 
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