Regulatory Services

Drug Product

NeoCubes can support you in your regulatory requirement for Europe, US, Australia, Canada and Row countries. It can be divided under two parts;

Pre-Approval Support:

  • Regulatory Intelligence and Submission Strategy

  • Scientific Advice from technical expert or Authority (regulatory/clinical/strategic)

  • Controlled corresponded with USFDA

  • Dossier Due diligence / Gap Analysis

  • Dossier Drafting (According to EU/ANDA/ANDS/DINA,TGA/EAEU dossier)

  • Local representative service being as MAH

  • US Agent services for submission with USFDA

  • Module 1 drafting

  • Deficiency response drafting

  • EU national phase handling: RAEFAR in Spain, all EU countries, UK etc

  • Market Extrapolation with minimum requirement

  • Dossier submission management:

    • EU: DCP, National, MRP, Duplicate
    • UK portal submission
    • USFDA: ANDA or NDA
    • Canada: ANDS or DINA
    • TGA application
    • EAEU region dossier submission
    • GCC dossier

Post-Approval Support:

  • Life cycle maintenance in Europe: variations i.e.., Type IA/IAin, Type IB, Type II

  • Renewal application package preparation for Europe

  • Life cycle maintenance in USFDA: Annual report, CBE 0 or CBE 30 , PAS

Drug Substance

Pre-Approval Support:

  • Regulatory Intelligence

  • Regulatory Submission Strategy

  • Scientific Advice from technical expert or Authority (regulatory/clinical/strategic)

  • Controlled corresponded with USFDA

  • DMF Due diligence / Gap Analysis

  • DMF/ASMF Drafting (According to EU/USFDA/CEP criteria)

  • Deficiency response drafting

  • Market Extrapolation with minimum requirement

  • DMF submission management: EU/EDQM/USFDA/TGA/Health Canada

Post-Approval Support:

  • Life cycle maintenance in Europe: variations i.e.., Type IA/IAin, Type IB, Type II

  • Life cycle maintenance in USFDA: Annual report, CBE 0 or CBE 30 , PAS

Specific Modules

  • Readability testing report (Module 1.3.4 for EU submission)

  • Bridging report

  • Environmental risk assessment report

  • Elemental risk assessment report

  • Nitrosamine risk assessment report

Labelling and Artwork

  • Labelling drafting – SmPC, Leaflet, SPC, carton outer, immediate pack label

  • Artwork Preparation and its proof reading

  • Artwork/labelling change management

  • Promotional Materials/medico marketing material

eCTD/NeeS Publishing

NeoCubes can support you in your dossier/DMF publishing requirement for Europe, US, Australia, Canada and EAEU countries for human and animal medicinal dossier.

  • eCTD publishing

  • NeeS publishing

Case Study

NeoCubes can support you for Life cycle maintenance activities on annual contract basis, which is highly cost effective. Please refer case study:

Client with 20-30 Products portfolio

What if company (EU/US based) doing inhouse

  • General variations flow annually: 150 +
  • Staff requirement:
  • 2 Technical + 1 labelling staff
  • 1 eCTD
  • Annual cost to any company based in US/EU:
  • 3,00,000 - 3,50,000 USD including eCTD maintainance
  •  

What if company (EU/US based) outsource to NeoCubes

  • General variations flow annually: 150 +
  • Outsouring to NeoCubes:
  • Annual cost:
  • 1,50,000 – 1,80,000 USD including eCTD maintenance.
  • (Almost at 50% cost reduction)