Regulatory affairs services include dossier compilation for submissions to agencies around the world, regulatory operations like publishing submissions, clinical affairs such as medical writing and data management, labeling services, communicating with the FDA as the US agent, structured product labeling, setting up electronic submission gateways, using NextGen eCTD software to publish submissions to multiple global health authorities, and other regulatory support. The document lists various services provided across the product lifecycle to support global regulatory submissions and compliance.

1. Regulatory
Affairs
(Dossier Compilation CTD,
ACTD, NeeS, eCTD and
Country Specific Format)
Regulatory
Operation
(eCTD Publishing, Document
Leve and Submission
Level Publishing)
Regulatory
Labeling
(Labeling Content and
Art Work Development)
Clinical
Affairs
(Medical Writing, Protocol
Development and
Data Management)
US Agent
(FDA communication
i.e. meetings, queries, etc)
Structured
Product
Labeling (SPL)
(Drug Listing, ER, NDC and
GUDFA Self Identification)
Other Regulatory
Support
(ESG and NextGen
Portal setup)
NextGen
eCTD Software
(eCTD Publishing for US, EU,
CA, AU, GCC, CH, TH and JO)
Global Solutions
TM
NextGen eCTD Software