Regulatory Services

We provide a full range of Regulatory services for submission of dossier to deficiency to variation filling of all dosage form & to the Pharmaceutical and Healthcare Industries for regulated, semi-regulated and non-regulated market.

For the compilation of dossier, person needs to understand/interpret the guidance of respective agency & understand the product behaviour. CELUI have experience team of more than 10 years, who will support the client, not only for dossier compilation, but our team involve from the development stage of product, which enable the company to develop the product in line with countries regulation. CELUI has own process of preparing dossier, which will differentiate our self from other.

Regulatory Strategy:

  • CELUI team will support the client by identifying product related risk & providing guidance to overcome, during development
  • CELUI team will guide the client for multiple filling countries using the same batches data
  • CELUI team will make the strategy for post‐approval changes
  • Preparing regulatory framework and road map for approval
  • Identify the gap analysis of already filed product country & proposed country filling

Administrative Support

  • Hiring local affiliate (we our business associate based in ASEAN countries, CIS countries, Europe)
  • Establishment of eCTD software
  • Submission of dossier though ESG
  • Module 1 compilation as per country specific regulation
  • Artwork and labelling preparation as per country specific regulation
  • Dossier audit & translation services
  • Preparation of SmPC, Patient Information Leaflet as per country specific requirement
  • Communication to ministry of health on behalf of company for technical discussion

API:

  • Type II Drug Master File writing for US FDA submission & ASMF preparation for EU market
  • Support for US agent
  • Co‐ordination and execution of FDA inspection
  • Review of Drug Mater File (USDMF, EDMF, CEP / COS) & technical data
  • Drafting & review agency's query response
  • Compilation & review of variation/supplement as per agency's guideline

Finished product:

  • Compilation and review of Registration dossiers i.e. IND filling, ANDA filling (CTD, NeeS, eCTD & ACTD format) required to submit in various regulatory agencies all over the world
  • Compilation and review of non-clinical (Module 2.4 & 2.6) and clinical (Module 2.5 & 2.7) overviews
  • Getting expert review and report on Quality, Non-Clinical and Clinical
  • Compilation and review of deficiency response
  • Compilation and review of post-approval changes (variation / supplement)
  • Review of BE study protocol & BE study report

FDA Licensing:

  • Application for Product permission, CoPP, GMP, WHO GMP licensing
  • Embassy Attestation for legal documents
  • Manufacturing plant permission
  • BE NOC
  • Import application for medical devices & innovator product