NOVEL CONSULTANTS

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.

• Guidance in resolving critical regulatory queries related to formulations & API

  Regulatory queries are generally raised by regulatory agencies w.r.t. audit of facilities and documents submitted during filing ANDA & Dossiers/CEP &DMF 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