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NOVEL CONSULTANTS

Pharmaceutical Consultants


Date: 
Other Services

Other Services

  • Due-diligence for Pharmaceutical plants & CROs acquisition

    We provide services for technically evaluating Pharmaceutical Plants CROs (Clinical Research & Contract Research Organisations) for acquisition. Due-diligence is conducted by experienced team members and provides consolidated report regarding facilities and technical competency of the unit.
  • API & Formulation manufacturers’ audit as vendor development

    Vendor audit is done on contractual basis for clients, as a part of vendor development across the globe.
  • Guidance for implementing “Quality Management System” i.e. GMP, GLP & GCP

    Team of experts provide guidance to Pharmaceutical Units & CROs for training and implementing Good Manufacturing Practices, Good Laboratory Practices & Good Clinical Practices.
    We also help Pharmaceutical Units to upgrade the Facility & Quality Management System for approval by USFDA & EMA.
  • Help in resolving critical regulatory queries related to formulations

    Regulatory queries are generally raised by regulatory agencies w.r.t. audit of facilities and documents submitted during filing ANDA & Dossiers and sometimes they are very critical and difficult to response, so we help in replying adequately to such critical queries in order to satisfy regulatory agency.
  • Guide in designing plants as per USFDA & EMA guidelines






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