0

Regulatory services

Regulatory services
Regulatory services
Price And Quantity
  • 1000
  • Piece/Pieces
  • 10000.00 - 15000.00 INR
Product Specifications
  • For Hospital
  • Medicine Raw Materials
  • Suitable For All Ages
  • Dry Place
    Product Description

    Rudra Marketing Solutions – Regulatory Support Services

    We provide full range of Regulatory services for submission of dossier to deficiency to variation filling for all dosage forms, to the Pharmaceutical and Healthcare Industries for regulated, semi-regulated and non-regulated market.

    Below are the services which we offer:

    SR NO.

    REGULATORY SERVICES

    MARKET

    1.

    ADMINISTRATIVE


    1. Procedure Management

    All

    1. Communication with MOH

    1. eCTD Conversion

    1. Regulatory Training

    1. USER Testing

    EU




    2.

    TECHNICAL


    1. Development Support

    • Designing of Specification

    • Pharmaceutical development Report Review (PDR)

    • DMF Review/ Technical pack Review

    • Packaging material selection

    All

    1. Preparation, Compilation & Review of 2.4 & 2.5 Module ((For Generic/Hybrid/Bibliographic application)

    EU

    1. Preparation, Compilation & Review of Risk Management Plan (RMP)


    1. Review of RTR (Refuse to receive standard) as per RTR Guideline

    US

    1. Review of Dossier as per ANDA Checklist


    All

    1. Review of BA/BE Study as per MOH Guideline

    1. Due Digilance of Dossier





    3.

    POST – APPROVAL


    1. Variation Filing / Supplement Filing

    EU/US

    1. Pharmacovigilance Services

    • PSUR / PABER

    • Literature Review

    • Aggregate Report Compilation

    • EVMPD Database Entry


    Trade Information
    • Cheque
    • 1000 Per Day
    • 1 Week
    • Yes
    • Sample costs shipping and taxes has to be paid by the buyer
    • Carton Box
    • Africa, Middle East, Western Europe, Eastern Europe, South America, North America, Central America, Australia, Asia
    • All India
      Contact Us

      Shop no.7, Public Weigh Bridge Compound, Plot No- 313 Phase 2, Vatva Gidc,, Ahmedabad, Gujarat, 380061, India
      Phone :+918068096630