Titenare Gxl Technologies Private Limited

Become the proven, trusted and value-added one stop solution provider to the Pharmaceutical, Food, Healthcare, Personal Care, Device and Electronic Industries.

Regulatory Affairs Services & Support on-Demand

  • Competent team to undertake complete requirements for the Client’s geography
  • Review of documents from R&D, Bioequivalence studies, API manufacturer and formulations manufacturing for NDA, sNDA, ANDA/eCTD readiness; 510K/CE/UL/ISO/IATF readiness, gap analyses and gap closure advisory.
  • Compilation of NDA, sNDA, ANDA/eCTD, 510K/CE/UL with necessary coordination with various entities
  • Submission of eCTD for EU, ANDA’s for USA, or any other geographic filings. Work with specific, compatible database tools
  • Running Centralized procedures like Centralized/MRP/DCP (EU)
  • Running of procedures for ANDA, and DCP/MRP, national phases
  • Advisory on optimum filing strategies to reduce approval time and costs, filings & queries management, with customer as front end
  • Guidance to R&D team during product development stages to ensure streamlined ANDA/eCTD/510K/CE/UL approvals
  • Management of post approval changes / variations, renewals, and optimum strategies
  • Review of active substance Drug Master File and actions closure
  • Screening of in-licensing dossiers for registration success
  • Coordination with Manufacturing, R&D, Quality, Artworks, Pharmacovigilance, and other functions for smooth integration of all ANDA/eCTD/510K/CE/UL documents to ensure regulatory compliances.
  • Regulatory budget setting and costing based on Client product pipeline plans.
  • Optimum regulatory planning for site transfer and technology transfer projects; establishing, gathering, and compiling documents for filing variations and new sourcing strategies
  • Specific project based
  • Rent-a-resource: Monthly retainer based
  • Resource placement at the manufacturing sites

Business solutions and services

Access to right Products & Funding


  • Strategy and branding
  • New Product Strategies – R&D, In licensing, out licensing
  • Global product development
  • Mergers & Acquisitions
  • Advisory services
  • Turnkey project solutions
  • Fund raising support

Access to integrated Services


  • Project Management
  • Facilities Design & Engineering
  • Regulatory Affairs – Drug & Device
  • Quality Management Systems
  • Development Services – Product/Analytical
  • API Development Monitoring Support
  • Technology/Site Transfers
  • Third Party Audit and Compliance
  • ISO//CE Mark/UL certifications
  • Global Supply Chain Management
  • Intellectual Property

Access to right Markets


  • Market Assessment
  • Competitor Differentiation
  • Strategy and branding
  • Pipeline Prioritization
  • Competitor and customer perspectives
  • Complete organization value maps.
  • Implementation planning and support
  • Market access: India, EU, US, RoW