Medical Writing and Review

Medical Writing and Review
Product Description

Extensive experience in writing and review of regulatory and scientific documents across the clinical life development life cycle of drugs, biosimilars and vaccines. 


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ARKUS RESEARCH PRIVATE LIMITED

  • IN
  • 2023
    On CPHI since
  • 1 - 24
    Employees
Company types
Consultancy
Contract Research Organisation (CRO)
Contract Service
Other
Primary activities
Clinical Research
Contract Research Organisation
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Categories
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Specifications
  • Details
    Protocol Writing & Review, CRF Design & Review, Clinical Study Report & CTDs, Investigator Brochure, Product Updates & Brochures, SOPs Development & Review.

    Regulatory strategy & support including development of INDs, PINDs briefing books, query responses, Pediatric Waiver plans etc.
  • Selling Points
    Quality Service; Reputation; Experience with one-on-one regulatory interactions, multiple markets, very high-quality deliverables. 

  • Model
    Remote, Scope based
  • Supplied from
    India
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Sales Markets
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ARKUS RESEARCH PRIVATE LIMITED

  • IN
  • 2023
    On CPHI since
  • 1 - 24
    Employees
Company types
Consultancy
Contract Research Organisation (CRO)
Contract Service
Other
Primary activities
Clinical Research
Contract Research Organisation
View company profile

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ARKUS RESEARCH PRIVATE LIMITED resources (1)

  • Arkus Research Private Limited

    Brochure Arkus Research Private Limited

    Arkus Research is an India based service provider for Monitoring, Audits and Vendor Qualification for bioequivalence studies. Additionally, we provide Medical Monitoring, Support for regulatory queries and Document preparation (USFDA), QMS assessment and RWE strategy and solutions. The Arkus team is a well experienced team with a very sound understanding of operational and regulatory requirements of your studies.

    Reach out to us for compliant, effective solutions with a focus towards excellence.