Safeguarding
Your Success with
Precision & Confidence
At Acknown Pharma, we understand that quality, compliance, and regulatory excellence are critical pillars of pharmaceutical success. Our dedicated teams offer tailored solutions to navigate complex regulatory environments, ensure strict compliance with quality standards, and manage risks effectively. With our comprehensive services, your pharmaceutical products achieve seamless regulatory approval, maintaining impeccable quality that secures your competitive edge.
Our Quality & Compliance Services
Quality
Achieve excellence through robust quality management systems, ensuring your products consistently meet stringent global standards.
- GMP Audits (API & Finished Dosage Form): We conduct detailed GMP audits for both APIs and finished dosage forms, ensuring your manufacturing processes are compliant with international GMP requirements. Our rigorous audits identify risks, recommend actionable improvements, and strengthen your compliance posture.
- Triggering Plant GMP Compliance: Our proactive approach includes identifying and rectifying potential compliance issues early, ensuring your production facilities adhere rigorously to GMP regulations. This ensures seamless regulatory inspections and uninterrupted market presence.
- Qualified Person (QP) Services for EU: We provide highly experienced Qualified Person services, essential for releasing pharmaceutical batches within the EU. Our QP experts certify compliance with all relevant regulations, ensuring your products maintain integrity from manufacturing to market.
- Release and Testing Services: Our comprehensive testing and batch release services ensure that each product meets stringent quality specifications and regulatory requirements, reducing risks and enhancing product reliability and patient safety.
Our Regulatory Services
Regulatory
Navigate complex regulatory landscapes efficiently with our strategic guidance and comprehensive documentation support.
- Dossier Compilation: We deliver expert dossier compilation services, meticulously organizing your regulatory submissions to meet international standards such as CTD, eCTD, and ACTD. This ensures faster review times and smoother approval processes.
- Dossier Due Diligence: Our due diligence processes rigorously evaluate your regulatory dossiers, identifying gaps, discrepancies, and compliance risks. This meticulous approach helps you address potential issues proactively, avoiding costly delays.
- Advisory Filing Strategy & Query Responses: Benefit from strategic regulatory guidance tailored specifically to your needs. Our expert teams support your filing strategies, handle regulatory queries efficiently, and ensure prompt, accurate responses, expediting approvals.
- Pharmacovigilance: Safeguard patient safety and product reputation with our comprehensive pharmacovigilance services. We proactively monitor drug safety profiles, manage adverse event reporting, and ensure ongoing regulatory compliance, reinforcing patient trust and regulatory confidence.