- Introduction
Preparing and reviewing Structural Product Labelling (SPL) for ANDA (Abbreviated New Drug Application) and NDA (New Drug Application) applications is a critical regulatory service provided to pharmaceutical companies seeking approval for their drug products from the FDA (Food and Drug Administration) in the United States. Here’s a detailed overview of these services:SPL is a standardized format for submitting drug product information electronically to the FDA.It includes comprehensive data about the product, such as indications, dosage forms, strengths, routes of administration, and labeling information.FDA requires SPL submissions as part of the regulatory application process for both new drug applications (NDA) and abbreviated new drug applications (ANDA). It ensures consistency, accuracy, and accessibility of drug product information for regulatory review and public access.
- Labeling Information: Detailed description of the drug product’s labeling, including indications and usage, dosage and administration, contraindications, warnings and precautions, adverse reactions, and other relevant sections.
- Product Information: Identification of the drug product, such as NDC (National Drug Code), brand name, active ingredients, strength, dosage form, and route of administration.
- Facility Information: Manufacturing establishment(s) involved in producing the drug product.
- Services Offered for SPL Preparation and Review:
- Content Development: Working with pharmaceutical companies to compile and organize necessary information required for SPL submission.
- SPL Authoring: Creating SPL documents in compliance with FDA’s eCTD (electronic Common Technical Document) specifications and SPL implementation guides.
- Formatting and XML Tagging: Properly formatting SPL documents and tagging data elements according to FDA’s SPL schema to ensure compliance and readability.
- Submission Management: Assisting in integrating SPL documents into the overall eCTD format for electronic submission to FDA.
- Coordination with Other Documents: Ensuring alignment and consistency between SPL documents and other components of the regulatory application, such as clinical data summaries and manufacturing information.
- Submission Management: Assisting in integrating SPL documents into the overall eCTD format for electronic submission to FDA.
- Coordination with Other Documents: Ensuring alignment and consistency between SPL documents and other components of the regulatory application, such as clinical data summaries and manufacturing information.
- SPL Review: Conducting thorough reviews of SPL documents to ensure accuracy, completeness, and compliance with FDA guidelines and regulations.
- Quality Control: Implementing quality control measures to verify that all required sections and data elements are included and correctly formatted.
- Validation Checks: Performing validation checks to ensure SPL documents are error-free and meet FDA’s technical specifications. Regulatory Strategy and Consulting:
- Regulatory Guidance: Providing strategic advice and guidance on SPL requirements, submission timelines, and regulatory pathways for both NDA and ANDA applications.
- Regulatory Intelligence: Keeping abreast of changes in FDA regulations, guidelines, and best practices related to SPL submissions.
- Regulatory Compliance: Proper preparation and review of SPL documents ensure compliance with FDA regulations, facilitating timely review and approval of NDA and ANDA applications.
- Accuracy and Consistency: Ensuring SPL documents are accurate, complete, and consistent with FDA guidelines enhances the credibility and reliability of the regulatory submission.
- Efficiency and Timeliness: Streamlining SPL preparation and review processes helps pharmaceutical companies meet regulatory timelines and expedite market approval for their drug products.
