Biological

  • Cosmetics

Introduction

Biological products, or biologics, are medical products. Many biologics are made from a variety of natural sources (human, animal or microorganism). Like drugs, some biologics are intended to treat diseases and medical conditions. Other biologics are used to prevent or diagnose diseases. Rbridge Lifesciences support the client in filing of dossier as required and do gap assessment and provide successful filing of the application.

Examples of biological products include

  • Vaccines
  • Blood and blood products for transfusion and/or manufacturing into other products
  • Allergenic extracts, which are used for both diagnosis and treatment (for example, allergy shots)
  • Human cells and tissues used for transplantation (for example, tendons, ligaments and bone)
  • Gene therapies
  • Cellular therapies
  • Tests to screen potential blood donors for infectious agents such as HIV

Regulatory Services

Regulatory Intelligence

  • Country
  • Category

Publishing and Submission

  • Global eCTD submission Publishing and submission services
  • Nees Submission
  • Category
  • Medical Device
  • Active substances master file Submission
  • Certificate of suitability Submission (CEP)

About

A full Portfolio of Capabilities to deliver Measurable Results for clients Regulatory affairs Market intelligence and filing strategies. Regulatory filings at USA/ EU/ Emerging Markets Emerging Market Tender activities and support to participate thru capable distributors & facilitators

Services

  • Drugs
  • Cosmetics
  • Biological
  • Medical Device
  • Diagnostic Kit
  • Food Regulatory Service
  • CRO

Contact

Rbridge Lifesciences Pvt Ltd

  • info@rbridge.in
  • maya.singh@rbridge.in
  • 7977768788
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