PHARMA QA

Quality Management and Assurance Solutions for the Pharmaceutical Industry

At Key2Compliance, we understand the critical role of regulatory compliance in the pharmaceutical industry. Our expertise in quality management and assurance is tailored to help companies, large and small, navigate the complexities of GCP, GVP, GMP, GDP, and GLP. This focus allows our clients to concentrate more on what they do best: innovating.

We can guide you through every phase of the product life cycle, ensuring that you meet the intricate regulatory requirements. Our team has substantial industry experience and attend to your business needs, works diligently to ensure your products achieve quality standards and align with GXP compliance – effectively and efficiently.

Rely on our Quality Assurance services for Pharmaceuticals

At Key2Compliance, we are dedicated to assisting pharmaceutical producers in navigating critical areas of Pharma QA. Our expertise and services are tailored to help you maintain product quality, safety, regulatory compliance, and operational efficiency throughout all stages of development, manufacturing, distribution, and post-marketing activities.

GxP (Good X Practices)

We help you ensure compliance with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), Good Clinical Practices (GCP), Good Pharmacovigilance Practice (GVP) and Good Distribution Practices (GDP) to maintain high-quality standards throughout the product lifecycle.

Audits

Our team of competent and certified auditors help you understand the regulations, and meet the requirements optimally, by performing self-inspections, mock inspections, or perform coaching before authority inspections. Our services also include supporting your organization’s supplier management process by performing audits of your critical suppliers.

Validation/Qualification

For your qualification and validation activities, we are offering project management, support to produce documentation, and project QA support to ensure the robust performance of your systems, processes, and equipment for maintaining consistent product quality and regulatory compliance.

Quality Risk Management (QRM)

Our expertise helps you implement systematic processes for assessing, controlling, and mitigating risks, ensuring the quality and safety of your products throughout their lifecycle.

Quality Management Systems (QMS)

We collaborate with you in designing QMS and quality processes, selecting and implementing eQMS (electronic Quality Management Systems), offering validation support, and providing project QA support. Together, we establish a robust framework for maintaining consistent product quality and regulatory compliance.

QA/QP/RP/QPPV
Consultancy Services

Our consultancy services cover GAP analysis, coaching, expert advice, and the availability of part-time QA managers. We offer valuable guidance and support, helping pharmaceutical producers achieve and sustain high-quality standards, regulatory compliance, and operational excellence.

Ensure patient safety through robust Quality Management

Quality throughout the pharmaceutical lifecycle is crucial for product safety and efficacy. Compliance with industry regulations is essential for all stakeholders. Navigating and applying these regulations can be challenging, but robust Quality Management is essential for compliance and success.

Tailored support for all GxP sectors

Key2Compliance provides expert quality management support across all GxP sectors—GCP, GVP, GMP, GLP, and GDP. We offer tailored solutions, from establishing quality systems to quality assurance and advisory, ensuring your product’s quality and regulatory adherence. Our experienced consultants deliver a broad spectrum of services to diverse companies.

Rely on our experts

“At Key2Compliance, our dedicated team brings a wealth of experience and understanding of the pharmaceutical industry’s unique challenges. We pride ourselves on offering tailored, comprehensive solutions in quality management and assurance, ensuring our clients not only meet but excel in regulatory compliance.

Our approach is always client-focused, aiming to simplify complexities and foster innovation.”

Charlotta Hjerpe, Director Of Pharma Quality Assurance

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