Quality Management Systems Excellence

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Summary: Design, implementation, harmonization, and optimization of robust QMS (GMP, ISO 13485, ISO 9001, MDSAP, ICH Q7/Q9/Q10). Includes gap analysis, remediation, SOP development, training, documentation management, and continuous compliance support. Expertise extends to Halal, Kosher, and Animal-Origin Free certification processes.

In today's stringent regulatory environment, a robust Quality Management System (QMS) is essential for ensuring product safety, efficacy, and compliance. Regal Intel provides comprehensive QMS services designed to build and maintain a strong foundation for your regulatory success. Our team of highly specialized experts assists in the design, optimization, and implementation of QMS compliant with global standards, ensuring your operations meet the highest quality benchmarks.

• We develop tailored QMS solutions that align with your specific product type and regulatory requirements.
• Our expertise covers a wide range of standards, including GMP, ISO 13485, ISO 9001, MDSAP, and ICH guidelines.
• We ensure your QMS is efficient, effective, and adaptable to evolving regulatory landscapes.
• We harmonize processes and ensure decisions are made in the right system and are not redudant or conflicting.

• Internal Audits: We conduct thorough internal audits to assess your QMS's effectiveness and identify areas for improvement, ensuring ongoing compliance.
• 3rd Party Audits: We assist in preparing for and managing 3rd party audits, including those required for certifications like ISO 13485 and MDSAP.
• Mock Audits for FDA Inspection and Notified Body Inspection: We conduct realistic mock audits to simulate regulatory inspections by the FDA and Notified Bodies, providing valuable insights and readiness assessments.

• We conduct detailed gap analysis to identify areas for improvement, enabling you to proactively address potential compliance issues.
• We develop remediation plans to address identified gaps, ensuring your QMS meets regulatory requirements.

• We provide ongoing support to ensure sustained compliance throughout your operations.
• Our services include SOP development, training, and documentation management.
• We stay abreast of regulatory updates, ensuring your QMS remains current and compliant.

• Supplier Qualification: We assist in developing and implementing robust supplier qualification programs to ensure the quality and compliance of materials and services.
• Supplier Audits: We conduct supplier audits to assess their QMS and compliance, minimizing risks and ensuring consistent quality throughout your supply chain.

• We can assist with the optimization of your supply chain, and ensure good distribution practices.
• We also assist with Good Clinical Practices (GCP) for clinical trial compliance.

• We provide expert guidance on adherence to ICH guidelines, ensuring your clinical trials, manufacturing, and quality systems meet international standards.
• Our expertise covers ICH Q7 (GMP for APIs), ICH Q9 (Quality Risk Management), ICH Q10 (Pharmaceutical Quality System), and other relevant guidelines.

• We assist companies in navigating the requirements for Halal certification, ensuring products comply with Islamic dietary laws.
• Our services include guidance on ingredient sourcing, manufacturing processes, and documentation requirements for Halal certification.
• We can assist with any required audits for Halal certification.

• We provide expert guidance on Kosher certification, ensuring products meet Jewish dietary laws.
• Our services include assistance with ingredient verification, manufacturing process review, and documentation preparation for Kosher certification.
• We can assist with any required audits for Kosher certification.

• We assist companies in obtaining Animal-Origin Free certification, ensuring products are free from animal-derived ingredients and materials.
• Our services include guidance on ingredient sourcing, manufacturing process verification, and documentation requirements.
• We can assist with any required audits for Animal-Origin free certification.

• Global Expertise: Our team possesses in-depth knowledge of international QMS standards and regulatory requirements.
• Tailored Solutions: We develop customized QMS solutions that meet your specific needs.
• Proactive Approach: We help you anticipate and address potential compliance issues.
• Comprehensive Audit Services: We provide a full range of audit services to ensure your QMS is robust and compliant.
• Supplier Expertise: We assist in managing supplier quality and compliance.
• Certification Expertise: We assist in Halal, Kosher, and Animal-Origin Free Certification.
• Continuous Improvement: We provide ongoing support to ensure sustained compliance and quality excellence.