Regulatory Intelligence combined with our Operational Expertise enables us to support your trials according to the latest Agency Developments.
In a highly regulated and ever changing regulatory environment our eCTD submissions publishing experts make sure pharmaceutical companies’ submissions publishing requirements are fulfilled comprehensively. We help our clients navigate through FDA’s eDRL, SPL process with guaranteed 100% accuracy. Our global outlook helps our clients leverage a scalable and efficient Labelling and Artwork Management that is cost effective and built to suit the needs of the global life sciences industry.
Submissions Publishing Services :
Agati Clinical as your comprehensive submissions publishing partner has Global Regulatory submissions expertise in NDA, BLA, MAA, ANDA, IND, NDS, DMF, CTA, supplements, amendments, variations and SPL to name a few.
Our submissions publishing services include:
• Submissions Project Plan, submission map creation.
• Submission compilation & Lifecycle Management.
• Submission document development/ document publishing.
• Agency Specific document formatting and Publishing.
• Develop CTD structure and document content plan.
• eSubmissions Gateway setup.
• Paper to Electronic document conversion.
• Enable eDMF submission in eCTD format by providing, document mapping, lifecycle management including amendments and annual reports & electronic signatures.
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Labelling and Artwork Services:
Our services in Labeling and Artwork include the following :
• SPL submission packages creation for NDC/ NHRIC labeler code request
• Drug establishment registration and listing.
• In-depth SPL Validation for FDA compliant SPL submission
• Checking format data values e.g. DUNS Number, FEI number, Labeler code etc.
• Lifecycle Management for SPL submission & conversions
