Services

Consultancy Services

Protaccine Biotec provides a wide range of expert consultancy and training services in the areas of conceptualization, basic & detail engineering, design & construction, process development, production, quality control, quality assurance, regulatory documentation and gap analysis to achieve International Accreditations. We provide technical support to companies manufacturing Vaccines, Bio-Pharmaceuticals, APIs, Finished Products, Bio-Similar Drug Substance (DS) and Bio-Similar Drug Product (DP) and Herbal DS & DP. We provide project management on turnkey basis at optimized costs.

  • WHO Pre-Qualification
  • GAP Audit & Recommendations
  • Risk Based GMP Inspection
  • Audit Findings Responses & CAPA
  • Due Diligence for acquisition
  • GAP III Certifications
  • Biosafety Audits
  • GMP, Hands-on & Behavioural Trainings
  • Quality Management System
  • Quality Risk Management
  • Qualification & Validation
  • Continuous Improvement Consulting
  • Process Development & Technology
  • Project Management
  • Complete Project Documentation
  • Risk Based Facility Design & Design Review
  • Conceptual Layouts & Detailed engineering
  • Construction Scheduling, Management & Supervision
  • Pre-commissioning & commissioning
  • Supply of Bulk & Finished Products
  • Supply of Major Pharma Equipments

Details