With over 16 years of proven expertise, NYPL Services is your trusted partner for outsourcing solutions in the pharmaceutical industry. We deliver reliable, compliant, and results-driven services tailored to your needs. Ready to elevate your operations? Contact us today and experience industry-leading support you can count on.
NYPL Services provides comprehensive solutions tailored to the pharmaceutical and biotechnology industries. Our expert team offers a wide range of consulting services, combining academic excellence with hands-on experience to meet your business needs.
Ensuring your organization meets FDA and international GMP standards, we help you navigate complex regulatory requirements with ease. Our services include Change Control Management, SOP's Development, Investigation Management, CAPA, Effectiveness Checks, and the implementation of Ichikawa (fishbone) methods, among many other services.
We specialize in creating and managing GMP documentation, including SOPs, Change Control, Investigations, CAPA, and Effectiveness Checks, to ensure operational excellence.
Our team ensures compliance with 21 CFR Part 11, providing validation services for computerized systems to safeguard data integrity and regulatory adherence.
Our process validation services ensure that all manufacturing processes meet GMP standards and regulatory requirements. We specialize in GMP Pharma Process Validation, New Product Transfer Validation, and assisting with Regulatory Submissions to ensure successful approvals and smooth operations.
Our experienced project managers ensure that your projects are delivered on time and within budget while maintaining the highest quality standards.
We provide validation services following the GAMP5 guidelines, ensuring that your computerized systems are fit for their intended use and comply with regulatory requirements.
NYPL Services is an innovative consulting firm specializing in providing comprehensive solutions tailored to the unique needs of the pharmaceutical and biotechnology industries. With a team of highly skilled professionals, we combine extensive academic knowledge with real-world, hands-on experience to deliver impactful results.
Our expertise covers a broad range of services, including regulatory and compliance support, ensuring that our clients meet and exceed industry standards such as FDA and international GMP regulations. We specialize in the development and management of GMP documentation, including Standard Operating Procedures (SOPs), Change Control processes, Investigations, Corrective and Preventive Actions (CAPA), and Effectiveness Checks, all aimed at maintaining operational excellence and regulatory compliance.
We also provide robust solutions for Computer System Validation (CSV), ensuring compliance with 21 CFR Part 11 for electronic records and signatures, critical for maintaining data integrity and security in computerized systems. Our team is well-versed in process and equipment validation, offering end-to-end services to ensure that all systems, equipment, and processes are properly validated and ready for regulatory inspections.
By partnering with NYPL Services, your organization will benefit from our in-depth understanding of industry best practices, innovative solutions, and a proactive approach to tackling complex challenges in regulatory compliance, validation, and quality assurance. Our goal is to support your company in achieving seamless operations while staying compliant with the latest regulations and industry standards.
Email: sales@nyplservices.com | Phone: 787-635-7770