CRO Regulatory Services

Introduction

A contract research organization (CRO) is a company that provides support to the pharmaceutical, biotechnology, and medical device industries in the form of research services outsourced on a contract basis. A CRO provide services as biopharmaceutical development, biologic assay development, commercialization, preclinical research, clinical research, clinical trials management, and pharmacovigilance.
CROs are designed to reduce costs for companies developing new medicines and drugs. They aim to simplify entry into drug markets, and simplify development.

CROs also support foundations, research institutions, and universities, in addition to governmental organizations (such as the NIH, EMA, etc.). CROs specifically provide clinical-study and clinical-trial support for drugs and/or medical devices.All imported cosmetic products covered under definition of cosmetic are regulated under the provision of Drugs and Cosmetics Act, 1940 and Rules, 1945.
Drugs Controller General (India), Central Drugs Standard Control Organization (CDSCO regulate the import of cosmetics in India.

Requirement

Rbridge Lifesciences have reliable, industry experts who assist our clients to collaborate with the CRO as per their requirement.

  • Clinical Trial Services
  • Medical Writing
  • Clinical Operations (Phase II-IV, Non-Interventional Studies)
  • Site Management
  • Project Management
  • Biostatistics
  • Bioequivalence/Bioavailability (BE/BA) Study
  • Clinical Data Management
  • e-Clinical Solutions
  • GDPR Services
  • Regulatory report preparations
  • PV report writing

Biopharmaceutics and Bioequivalence

Bioequivalence study protocol development and review
Failure analysis for BE study results and way forward for successful BE study
BE study regulatory query response
Dissolution method justification and dissolution similarity analysis for regulatory queries
Modeling and simulations for lead formulation selection for BE study
IVIVC/Modeling and simulations for dissolution target assessment.

Clinical Services (Phase II/III/IV)

ICH GCP Training of sites including current regulatory requirements for India
Development of Monitoring Plan, Clinical Operations Plan and Communication Plan for Phase II/ III studies
Development of Risk assessment plan for RBM studies
Training of Onsite and In-house CRAs -Training would include ICH GCP training, soft skill training, as well as training on report writing
Training of Onsite and In-house CRAs -Training would include ICH GCP training, soft skill training, as well as training on report writing

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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