GMP Audits & Compliance

• GMP Audits: Our experts conduct rigorous, gap-free audits aligned with FDA, EMEA/MHRA, and global standards. We go beyond compliance—we identify risks, streamline processes, and future-proof your operations.

• Vendor Qualification: Trust but verify. We rigorously evaluate suppliers to ensure your supply chain meets GMP standards, reducing risks of delays or recalls.

• Mock Inspections: Fear no inspection. Our mock FDA, MHRA, and PAI/BLI simulations replicate real-world scrutiny, equipping your team to respond confidently.

• Remediation & Compliance Assurance: From 483 Observations to Consent Decrees, we turn regulatory challenges into opportunities. We fix gaps, implement corrective actions, and ensure continuous compliance as regulations evolve.

Quality Management Systems (QMS)

• QMS Implementation & Remediation: Whether building a new QMS or overhauling an outdated one, we align your systems with EMEA/MHRA/FDA requirements. Our eQMS solutions (like Dot Compliance) digitize workflows for real-time compliance tracking.

• Document Optimization: SOPs, batch records, policies—we craft clear, actionable documentation that reduces errors and accelerates training.

Quality Assurance (QA)

• Deviations & CAPA Management: When issues arise, we don’t just find root causes—we eliminate them. Our CAPA plans are actionable, sustainable, and designed to prevent recurrence.

• QP/RP Support: Struggling with Market Importation Authorisation (MIA)? Our Qualified Persons (QPs) handle product releases and licensing, ensuring seamless market access.

• Mock Recalls: Test your recall readiness with our simulations. We help you refine procedures to protect patients and your reputation.

Validation & Qualification

• CQV Services: From lab equipment to full-scale facilities, we validate every step to meet FDA/EMA guidelines. Our protocols ensure your processes are reproducible, compliant, and audit-ready.

Lifecycle & Commercial Support

• Clinical-to-Commercial Transition: Scale quality systems smoothly from clinical trials to commercial production.

• Engineering & Project Management: We deliver GMP-compliant facilities on time and within budget, blending technical expertise with regulatory insight.

Why Molgenium?

More Than Consultants—We’re Your Strategic Partners

• Global Expertise, Local Insight: Our team includes ex-regulators, seasoned QPs, and Six Sigma Black Belts who speak the language of compliance and innovation.

• Tailored Solutions: No cookie-cutter approaches. We adapt to your unique needs, whether you’re a startup or a global enterprise.

• End-to-End Support: From audit to approval, we’re with you at every milestone.

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