0 Cookie Img

Regulatory services

Regulatory services
Regulatory services
Product Code : 01
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


Contact Us

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