Product Information
Details about the product, including its composition, formulation,
manufacturing
process, intended use, indications, contraindications, and dosage.
Clinical Data
Information from clinical trials and studies conducted to assess the safety
and
efficacy of the product. This may include study protocols, clinical trial
results,
adverse event reports, and pharmacovigilance data.
Quality Data
Data related to the quality control, manufacturing processes, and quality
assurance
measures implemented during the production of the product. This may include
manufacturing records, batch records, stability data, and certificates of
analysis.
Regulatory Submissions
Documents submitted to regulatory agencies for product approval, such as new
drug
applications (NDAs), biologics license applications (BLAs), premarket
approval
applications (PMAs), and marketing authorization applications (MAAs).
Labeling and Packaging Information
Information provided on product labels and packaging, including prescribing
information, patient information leaflets, package inserts, and labeling for
use in
specific populations.
Safety and Risk Information
Data on the product's safety profile, including adverse event reports, risk
assessments, and risk management plans.
Post-Market Surveillance Data
Information collected after the product is on the market to monitor its
safety and
effectiveness, including post-market studies, adverse event reporting, and
product
recalls.
Compliance Documentation
Documents demonstrating compliance with regulatory requirements, such as
good
manufacturing practices (GMP), good clinical practices (GCP), and good
laboratory
practices (GLP).
