Welcome to RBRIDGE

ABOUT RBRIDGE​

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. Assist In-house Regulatory Teams to sort and comply filing concerns. Global filing and registration, Life cycle management Gap Analysis for Market specific requirements – Technical/ Administrative and Regulatory Technical and regulatory support for API and Formulation development activities. Regulatory dossier filing end to end project management. GMP Deficiencies – Regulatory and Quality compliance/ CAPAs / Remediation action Plans Regulatory and technical aspects – Training onsite as well as Offsite classroom trainings.

Services available to clients

Pharma players – Just starting up, desire to expand their business in Regulated as well as Emerging Markets of the Globe.

  • Smaller companies, seeking assistance to prepare themselves with Global Regulatory & GMP standards
  • Looking for an assistance for product development and regulatory filings/ Handling the queries and Post approval amendments.
  • Complete project management / coordination for the facility, QMS and implementation activities on behalf of client or its service providers.
  • Compilation of eCTD dossiers and filing assistance using CESP and ESG for EU and FDA respectively.
  • Vendor qualification audits, Follow up audits and evaluations at suppliers
  • Third party assurance with capable resource available in USA, for USFDA liasonig and coordination.
  • Medical Devices ISO 13485 audit and compliance support
  • Support on outsourcing of Regulatory affairs and Quality Compliance function and substantially reducing financial burden of client due to Non compliance issues and remediation activities.

Products and dossiers being handled

  • Products and dossiers being handled
  • Active Ingredient and Advanced Intermediates
  • Intermediate DMF in NeeS and eCTD as per requirement
  • CEP compilation and submission to EDQM Formulations
  • Oral Solids – Tablets / capsules / Modified Release Formulations
  • Oral Liquids
  • Topical semi-solids – Gels / Creams / Ointments
  • Biologics – India and Emerging Markets filing
  • Medical Devices
  • EU, CA, AU filings
  • Strategy and Paving layout for USFDA filing
  • Support for ISO 13485 audit and compliance.

Global Regulatory Strategy

  • End To end Regulatory Affairs Project Management
  • QMS/ cGMP and Quality Compliance and CAPA activities
  • Facility Design and Validation Documentation as per Good Documentation Practices
  • Health Authority Inspection support / Pre-inspection Audit Services
  • Dossier in-licensing Audit / gap Analysis
  • eCTD compilation Outsourcing support *
  • EU Dossier Filing facilitation and QP and QC testing support.
  • Scientific and Technical Support.

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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