Labeling Regulatory Affairs
- 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 & Translational Services
- Structured Product Labeling (SPL) for NDC/NHRIC Labeler Code Request, Drug Establishment Registration, Drug Listing and GDUFA Self Identification