Qualified Person (QP) Services
At ClinovaPack, we offer a comprehensive range of Qualified Person (QP) services tailored to meet the diverse needs of pharmaceutical companies worldwide. Our team of experienced QPs ensures compliance with EU Good Manufacturing Practice (GMP) standards, assuring the quality, safety, and efficacy of investigational medicinal products (IMPs).
EU – GMP Audit of Manufacturing and API Sites Outside the EU
Partnering with ClinovaPack assures you of meticulous EU-GMP audits conducted on manufacturing and Active Pharmaceutical Ingredient (API) sites situated beyond the borders of the European Union. Here’s why our audit services stand out:
Global Compliance Expertise: Our seasoned professionals possess extensive knowledge of international regulatory requirements, ensuring that your facilities align not only with EU-GMP standards but also with global best practices.
Tailored Audit Solutions: We understand the nuances of each site and craft customized audit plans to address specific challenges and requirements, ensuring a thorough and effective assessment process.
Risk Mitigation Strategies: With our in-depth understanding of regulatory frameworks, we identify potential risks and provide proactive strategies to mitigate them, safeguarding your operations and reputation.
Comprehensive Assessment: Our audits go beyond surface-level inspections. We delve deep into your manufacturing processes, quality systems, and documentation practices to ensure compliance with the most stringent standards.
Examination of Finished Packs
With ClinovaPack, you can trust in the meticulous examination of finished packs to verify their compliance with regulatory specifications and quality standards. Our comprehensive inspection process ensures that every pack meets the necessary requirements for safety, efficacy, and traceability before reaching the market.
Provision of Regulatory Guidance
Navigating the complex landscape of regulatory compliance can be daunting, but with ClinovaPack by your side, you gain access to expert regulatory guidance in all areas of investigational medicinal products (IMPs). Our team offers invaluable insights and assistance to help you navigate regulatory hurdles seamlessly.
Partner with ClinovaPack
Unlock the expertise of seasoned professionals dedicated to enhancing your pharmaceutical operations. Benefit from personalized solutions designed to meet your unique needs and challenges. With a global network and a commitment to excellence, we streamline processes and ensure successful outcomes. Trust ClinovaPack as your partner for pharmaceutical success.
Validation Status of Facilities, Processes, and Methods
At ClinovaPack, we go beyond mere compliance to ensure that your pharmaceutical manufacturing operations adhere to the highest standards of quality and integrity. Our validation services encompass a comprehensive assessment of facilities, processes, and analytical methods, offering invaluable insights to optimize your operations and mitigate risks effectively.
Why Choose ClinovaPack?
Client Testimonials
