eCTD
• Expertise in eCTD submission management, planning, publishing strategy and repository
• Assist globally for Submission Management, Document Level (DLP) and Submission Level Publishing (SLP)*
• Support industry to harmonize electronic submissions (eCTD, NeeS and pCTD) as per health authority requirements
• Multi stage and Multi level review using eCTD QC checklist by experts before submission handover to client
• Experts to handle last minute changes/updates in dossier/submission
• To avoid delay in submission, constant project micro-management by team leads
• Kindly send requirements on “fidesraa@gmail.com/dhaarmi@fidesregulatory.com”
Submission Management
i.e. Data, Document Collection, Analysis and Planning, Initial Kick Start, Source Documents Review and Gap Analysis, Project Management Tracker and Updating the Dossier Documents based on Comments & Feedback with Troubleshooting etc.
Document Level Publishing
i.e. PDF conversion, Bookmarks, inter document Hyperlinks, ToC Generation, Page numbering, Internal document review and quality check and document updates based on review etc..
Submission Level Publishing
i.e. Data, Document Collection, Analysis and Planning, Initial Kick Start, Source Documents Review and Gap Analysis, Project Management Tracker and Updating the Dossier Documents based on Comments & Feedback with Troubleshooting etc.
Regulatory Labeling
• Expert in clinical labeling, medical device labeling, prescription drug labeling, OTC drug labeling, bulk Ingredient labeling, cosmetic labeling, homeopathic drug labeling, dietary supplement labeling etc.
• Expert Pharma Labeling Affairs professional for scientific review, compilation and finalization of submission documents like SmPC & package leaflet / insert (Prescribing Information – PLR and Non-PLR & Medication Guides)
• Development, proofreading and review of redline, clean copy and annotated comparison reports and container label/mock-up
• Artwork development like creation of drawings and specifications for all artwork components
• Content development like content write-up in adherence to applicable regulatory guidelines
• Regional specific labeling and updates like Text & Languages Translation Services
Structured Product Labeling (SPL)
• Expertise in preparation of Labeling Package (Package Insert, Medication Guide, Carton, Container Label and SPL)
• Expertise team has specialization in conversion of FDA compliant & validated SPL files (XML) using package insert / medication guide (clean copy and comparison document
• Conversion of Drug Labeling, NDC Label, Establishment Registration, GDUFA Identification in SPL XML format
• Ready pre-defined, tested and validated XML templates for varieties of FDA SPL’s
• Life cycle management of SPL (version and set id) by using all the standard parameter as per FDA specification
• Multiple stage review of COL, PDP and DLD section of SPL (Set ID, version No. DUNS number, NDC, Registrant, Labeler and Establishment Information) by Labeling SMEs SPL validation as per FDA compliant and specification (zero error)
Structured Product Labeling (SPL)
• Expertise in drafting of controlled correspondences, regulatory strategy & white papers
• Expertise in pre (original application & it’s amendment) & post approval (variations/supplement & annual report)
• Support to identify the gap analysis in dossier/submission during product development and manufacturing stage by considering regulatory authority requirements and standards
• Expertise in submission content writing with standard and peer review for all pre and post approval submission
• Precise response/justification to health authorities’ queries and screen all possible relevant queries
• Strategic support for product selection during Regulatory Planning & Project finalization
• “Fides Regulatory” provide US agent service i.e. communicate with FDA for pre-request meetings, for queries/deficiencies in dossier, sign in form and other relevant dossier documents, updation of ER on yearly base, pay fee for facilitates and dossier, dispatch of submission through ESG.
