a
alpa_jinjala

Ansh

@alpa_jinjala

Pharmaceutical Regulatory Affairs Labeling Expert

India
Inglés
Parte de la información aparece en idioma inglés.
Sobre mí
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.... Lee más

Habilidades

a
alpa_jinjala
Ansh
desconectado • 

Revisa mis servicios

Aprobación de la FDA y de la seguridad alimentaria
I will handle fda otc, rx and animal drug registration and listing
DeUSD 25 / proyectoMás información

Experiencia laboral

Freelance

Pharmaceutical Regulatory Affairs & Labeling Specialist

Freelance • Freelance

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.