Regulatory Services

Sarjen with its strategic regulatory services for regulatory submissions has helped many a growing Pharmaceutical and API manufacturing companies in growing their businesses considerably. Our dedicated consultants well supported with highly experienced technocrats have helped clients achieve verticals in their businesses. We are flexible to learn the guidelines set by Regulatory Authorities and can comprehend the business strategies ethically. Cost and time effectiveness have been the greatest concern in providing effective business solution and has formed the backbone of our consultancy services. Our understanding in Lifesciences and Pharmaceutical businesses along with that of various Regulatory Authorities has produced magnifying results.

Regulatory Submissions


Regulatory services in eCTD, NeeS, SPL R4, DMF and PADER

Paper to Electronic Submission – Baseline Submission

We help our clients transform from paper submissions to electronic submissions without much difficulty.

Paper CTD

eCTD

Compiled electronically with volumes,tabs and slipsheets,then printed to papper compiled electronically with edocuments in folders
Paper volumes must be A4 eDocuments canbe A4 or US letter size
CTD navigation by TOCs and volume eCTD navigation by XML backbone
Cross Refrences includes target CTD section number Cross Refrences are hyperlinked to targets
Manual document navigation by TOCs,page numbers,and caption cross-refrences Electronic document navigation by TOCs,bookmarks and hyperlinks
Submitted in binders in boxes on pallets by trucks Submitted on CD(or DVD?),or by email or portal

Regulatory Services

Regulatory medical writing Sarjen work as medical writer for creating the documentation that is required by regulatory agencies in the approval process of medicinal product such as clinical study protocols, clinical study reports and summary documents in module 5 of eCTD
eCTD/NeeS/DMF documents preparation, review and GAP analysis Sarjen provide service to prepare and review the eCTD/DMF documents which are required at the time of submission in US, EU, CA, GCC, SA, AU and CH and also perform the gap analysis, the difference between the actual conditions of document provided by client and the document requirement of regulatory authority
Pharma dossier (eCTD/NeeS/DMF) validation for all eCTD and NeeS accepting country Sarjen expertise in solving the difficult eCTD/eDMF/NeeS validation warnings and errors
Reply to regulatory authority queries Sarjen provide service to process any post submission queries from Regulatory Authority
US FDA ESG gateway submission Sarjen provide service to submit eCTD, DMF and SPL through ESG for the pharmaceutical companies
Prepare summary of product (SmPC) and pack information leaflet Sarjen expertise in preparing Pack Information Leaflet like SPL for US FDA and also can prepare PIL for EU, MCC and other countries
Pharma regulatory and registration procedure updates Sarjen keep clients updated with current and incoming regulatory events and share information to them via KnowledgeNET blog, Newsletters and emails
Other dossier submission key features click here