Regulatory Support

  • Regulatory Support 1
  • Regulatory Support 2
Product Description

Zenovel has a highly experienced team of experts who have a complete understanding of the complete requirements of Pharma Regulatory affairs throughout the drug life cycle. Our experts have experience in directly corresponding with Pharma regulatory authorities for various segments.

We provide complete support for Pharma Regulatory Affairs with our expert Regulatory Affairs Consulting Services for the global market, particularly in the USA & Europe.

From filing the Dossier till its submission, we provide solutions specific to the client’s requirements

 
A.   Regulatory Support during Drug Life Cycle:


✔ Regulatory Intelligence Services & De-Coding Dossier Requirements

✔ ...

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Zenovel

  • Country/Region:
    India
  • Founded:
    2020
  • On CPHI since:
    2021
  • Certificates:
    1
  • Employees:
    25 - 49
Company types
Consultancy
Contract Service
Start-up
Primary activities
Biopharmaceutical
Clinical Research
Medical Devices
Other
Regulatory Affairs
View company profile
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Specifications
  • Details
    Regulatory affairs and dossier support services for pharmaceutical companies, biotech companies, manufacturers, marketing authorization holders, and product development teams. Applicable for regulatory strategy, dossier preparation, medical/scientific writing, eCTD conversion, regulatory query response, variation filing, post-approval lifecycle management, Module 1 support, Module 2.4, Module 2.5, SmPC/PIL support, DMF support, stability documentation, dissolution documentation, and submission coordination.

  • Selling Points
    Brand Name; Experienced Technicians; Guarantee/Warranty; International Approvals/Standards; Product Performance; Prompt Delivery; Quality Service; Reputation; • Regulatory strategy and submission support for pharmaceutical products
    • IND, NDA, ANDA, IMPD and dossier documentation support
    • Module 1, Module 2.4 and Module 2.5 writing and review
    • Medical writing and scientific writing support
    • eCTD conversion and publishing support
    • Regulatory query response preparation and review
    • Variation filing and post-approval lifecycle management support
    • SmPC, PIL, DMF, stability and dissolution documentation support
    • Regulatory liaison and submission coordination support
    • Structured, practical and compliance-focused regulatory approach

  • Measured In
    US$
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Sales Markets
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Zenovel

  • Country/Region:
    India
  • Founded:
    2020
  • On CPHI since:
    2021
  • Certificates:
    1
  • Employees:
    25 - 49
Company types
Consultancy
Contract Service
Start-up
Primary activities
Biopharmaceutical
Clinical Research
Medical Devices
Other
Regulatory Affairs
View company profile

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