ClinVigilant provides inclusive regulatory operation services to Pharmaceuticals (FP and API), Biopharmaceutical, and Healthcare, CMO and Clinical Research industry and we are dealing with regulated and semi regulated markets for submission in electronic format (eCTD, Nees and pCTD format).

ClinVigilant Regulatory operations qualified expertise team has sound experience as Regulatory Operations professional which includes submission management/planning, publishing strategy, document level publishing (DLP), submission level publishing (SLP), submission dispatch to regulatory authorities, archival and troubleshooting.

ClinVigilant Regulatory Operations team has expertise in all kind of electronic submissions (eCTD and NeeS) like pre (original application, amendment to original application) and post approval (variations / supplement, annual report and PSUR / PADER) submission for US, Europe, Canada, Australia, South Africa and Gulf.

ClinVigilant electronic submission process flow

submission-process-flow

Countries and format in which ClinVigilant has expertise

Type for Format

  • eCTD – US, EU, Canada, GCC, Australia, Switzerland, South Africa, Thailand
  • NeeS – Australia, New Zealand, EU, Canada, GCC, Bosnia and Herzegovina
  • pCTD – Emerging market like LATAM, MENA, APAC, ASEAN, and CIS region
  • vNeeS – European region

Type of Services

  • eSubmission Management
  • Document/Submission Level Publishing
  • Regulatory Publishing On-site/Off-site
  • Regulatory Publishing Strategy
  • eSubmission Troubleshoot Assistance

Type of dosage form

  • Oral Solid Dosage Form (Tablets and Capsules)
  • Parenterals (Powder for Injection, Solution and Suspension)
  • Topicals (Cream, Ointments and Suppositories)
  • Others (Ophthalmic, Otic and Inhaler)

Type of Services

  • eSubmission Management
  • Document/Submission Level Publishing
  • Regulatory Publishing On-site/Off-site
  • Regulatory Publishing Strategy
  • eSubmission Troubleshoot Assistance

ClinVigilant provides Regulatory Operations / Publishing Support to Pharmaceuticals, Biopharmaceuticals, CMO and CRO

Qualified and experienced Regulatory Operations professionals who provide end-to-end Pharma regulatory publishing / operations (Submission Management, Document and Submission Level Publishing and Dispatch to Authority) support and services throughout the life-cycle of the product

Submission Management

  • Expert advice for Regulatory Operations planning / strategy / management like submission attributes, STF file tag, gap analysis, and life cycle operations, document tracking through eCTD checklist & document change history and eValidation troubleshooting with strict adherence to health authority requirements
  • Qualified and experienced Regulatory operation professionals who provide end-to-end publishing support and services (timely and high-quality submissions) throughout the life-cycle of product without any eCTD related deficiency
  • Team ClinVigilant assist pharma / healthcare industry with all required standards of Regulatory Publishing i.e. tools (PDF toolbox, eCTD Software and eValidator), submission checklist (file naming, leaf title, life–cycle operation), quality review checklist (pre, intermediate and post compilation) etc.
  • Team ClinVigilant support pharma / healthcare industry to harmonize their electronic submission (eCTD, NeeS and pCTD) process
  • To avoid delay in submission, constant project micro-management by team leads
  • Own Regulatory Publishing training program for all electronic submissions (eCTD and NeeS) requirements
  • Country-wise and client-wise, experienced and qualified team for end to end Regulatory Operations service i.e. document level (DLP) and submission level publishing (SLP)
  • Adopted culture and ethics to maintain confidentiality of client information
  • 24 x 7 client support (anytime and anywhere)
  • Multi stage and Multi level verification and review using QC checklist by experts before submission handover to client
  • Team of experts to handle last minute changes / updates in dossier
  • RO team is constantly tracking and updating internal processes and website blog for regulatory requirement and guidelines

Document Level Publishing

  • Team ClinVigilant assist pharma / healthcare industry for Document Level Publishing i.e. PDF documents conversions (bookmarks, hyperlinks, ToC etc)
  • Harmonized PDF conversion process in adherence to client’s internal standards and health authority requirements
  • Pre-defined templates for pCTD and NeeS submissions for EU, GCC, Canada, Australia and ROW / emerging markets.
  • Country- wise and client-wise dedicated Regulatory Operations professional (Document Level Publishers)
  • Multi stage review by using effective quality review checklist for pre-publishing activities
  • To track end to end document level publishing activities, we have project wise document tracker and change history documents and things needed to remind during PDF conversions
  • Team ClinVigilant assist in Study Report Level Publishing (SRLP) for Clinical Study Report (CSR) and Clinical Trial Authorisation (CTA) activities as per client internal standards and Agency reequipment

Submission Level Publishing

  • Submission Level Publishing team assist clients in all type of eCTD submissions i.e. Pre-approval (Original Application and its Amendments) as well as Post-approval (Supplement / Variations and Reports) for all eCTD accepting countries
  • Team ClinVigilant assist pharma / healthcare industry for Submission Level Publishing i.e. submission creation, document uploading, STF creation, external linking, compilation, validation / verification and dispatch of submission to health authorities
  • Country- wise and client-wise dedicated Regulatory Operations professional (Submission Level Publishers)
  • NeeS format and paper format to eCTD format conversion (baseline submission)
  • Multi stage review by using effective quality review checklist for post publishing and compilation activities
  • To track end to end submission level publishing activities, we have project wise eCTD tracker, metadata creation form, life-cycle management and change history documents and things needed to remind during submission dispatch
speak with our SME for regulatory operation