Regulatory Affairs
& Operations
Application
Writing
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eCTD Dossier
Application
Clinical trial reports
Common Technical
Documentation
Investigational New Drug
documents
New Drug Application
submissions
Sales materials
Posters
Regulatory Affairs & Operations is involved with every aspect of the business of pharmaceutical operation, from the earliest strategic development of an investigational drug, even before its first introduction to humans, to the commercial development, marketing, and distribution of a product through its entire life cycle as a mature commercial entity. This overreaching obligation of an RA function requires dedication and expertise in science and strategy across a number of technical areas, as well as operational expertise in required eCTD content, format regulations, and maintenance of files and records in manner consistent with an increasing worldwide presence of regulatory oversight.
Some of our services include:
» Biotech Operations start-up, gap analysis
» Acquisitions/migration
» New Drug Application (NDA)
» Marketing Authorization Application (MAA)
» Paper to electronic conversion
» eTMF
» Inspection Readiness
» CAPA/FDA Audits
» Clinical Development (Ops) Support
» Project Management
» Copyright & Literature References
» New Working Support Services
» Medical Information Services