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Ansh
@alpa_jinjala
Pharmaceutical Regulatory Affairs Labeling Expert
Indien
Englisch
Über mich
Helping pharmaceutical companies establishment registration, drug listing, labels review for human prescription, OTC and animal drug products with FDA compliant.
I can assist with:
Proof reading of labels in line with FDA labeling regulations.
Creation, validation and submission of Structured Product Labeling (SPL) to FDA.
Regulatory support for FDA submissions including Establishment Registration, Drug Listing, GDUFA Self-Identification, Labeler Code Requests, No Change Notification, and Blanket No Change Certifications.
Kompetenzen
Ansh
offline •
Meine Dienstleistungen
FDA-Zulassung und Lebensmittelsicherheit
I will handle fda otc, rx and animal drug registration and listing
Arbeitserfahrung
Pharmaceutical Regulatory Affairs & Labeling Specialist
Freelance • Freiberufler
Feb 2021 - Present • 5 yrs 8 mos
I have professional experience in pharmaceutical regulatory affairs, specializing in FDA labeling, Structured Product Labeling (SPL), drug establishment registration, drug listing, and regulatory documentation quality control. My experience includes reviewing, preparing, proofreading, and finalizing pharmaceutical labeling documents for prescription (Rx), over-the-counter (OTC) and animal products in accordance with applicable FDA regulations and guidance. Key Areas of Experience: FDA pharmaceutical labeling review, preparation, proofreading, and finalization. Prescribing Information, package inserts, Medication Guides, OTC Drug Facts, carton labels, container labels and animal drug labels. Structured Product Labeling (SPL) preparation, validation, quality control, and life cycle maintenance. FDA drug establishment registration, drug listing and renewal support. Drug listing, NDC labeler code, product and package information, and annual update activities. Blanket No-Change Certification, No Change Notification and GDUFA self-identification support. Regulatory labeling compliance review and documentation quality checks. Cosmetics labeling review for applicable regulatory requirements. I bring strong attention to detail, regulatory document review skills, and a quality-focused approach to supporting pharmaceutical companies and regulatory consulting organizations with accurate and consistent regulatory documentation.
