Aiding GMP control for product development and regulatory approval.
Quality Assurance (QA), Auditing, and Regulatory Affairs are critical functions in the pharmaceutical and biotechnology industries, ensuring that products are safe, effective, and compliant with regulatory standards. GRA provides support to organisations with experienced QPs and QA experts.
This may be required for clients that are reliant on CDMOs for their product development, providing QA, auditing and regulatory support such that compliance is maintained.
Quality Assurance focuses on ensuring that products meet predefined quality standards and where GRA can help organisations is in:
- Quality Management Systems: implementing Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs), tracking of raw materials/product to maintain product quality.
- Monitoring Production: overseeing manufacturing and QC processes, assessing deviations and designing solutions and risk assessments, to ensure consistency and compliance with quality standards.
- Conducting Inspections: regularly inspect facilities, equipment, and processes to identify and address potential quality issues and risks.
- Training Staff: ensuring that operators are trained in quality standards and procedures to reduce risk to product and regulatory submissions.
- Qualified Person (QP) release: ensures the product is fit for human use and releases to clinical trials.
- Internal & External Audits: conduct assessment of an organisation’s own compliance with internal and external standards.
- Continuous Improvement: using audit results to improve processes and enhance overall quality.
GRA can provide Regulatory Affairs support for multiple modalities to ensure that biopharmaceutical products comply with all regulatory requirements at any phase throughout their lifecycle. We can support such key responsibilities by:
- Regulatory Submissions: preparing and submitting documentation to health authorities (e.g., FDA, EMA) for product approval.
- Compliance Monitoring: keeping up-to-date with regulatory changes and ensuring ongoing compliance.
- Labelling and Advertising Review: ensuring that product labelling and promotional materials meet regulatory standards.
- Lifecycle Management: managing post-approval changes, renewals, and compliance updates.
By leveraging GRA’s expertise, we help organisations navigate the complexities of QA, Auditing, and Regulatory Affairs, ultimately enhancing and accelerating the likelihood of successful biopharmaceutical product development and regulatory approval.