Available Services
Regulatory Affairs
We specialise in providing end-to-end support from product development strategies to regulatory submissions. Our services include dossier compilation, regulatory CMC strategy, and dossier preparation. We manage regulatory submissions across multiple regions such as Singapore, China and Hong Kong. Additionally, we offer expert reports for quality, product license maintenance, and liaison with FDA and other notified bodies, ensuring compliance and facilitating market entry.
Training
ChemPharm provides customized training programs tailored to meet your specific requirements. Our offerings include comprehensive training in GMP, QSR, GDP, and GLP across 10 modular subjects. We prepare your team for FDA inspections, guide you through validation processes, and teach effective risk management strategies. Additionally, our training covers how to avoid warning letters and conduct clinical trials, ensuring your staff is well-equipped to maintain compliance and operational excellence.
Compliance
Our comprehensive compliance services ensure adherence to international regulatory standards to identify and mitigate compliance risks. Our expertise includes performing gap analyses, developing and upgrading Quality Management Systems (QMS), and enhancing GMP, GDP, GLP, and GCP compliance. We provide oversight for technology transfers, implement and improve CAPAs and deviations programs, and conduct independent third-party audits, including mock FDA audits.
Validation
We provide comprehensive validation services to ensure your systems and processes meet regulatory standards. Our services include developing validation strategies and programs, creating validation master plans, and preparing detailed validation documentation. We offer expertise in process validation, equipment qualification, and facility and utility validation. Additionally, we specialize in software and computer system validation, including 21 CFR Part 11 compliance and GAMP compliance gap analysis.
Flexible Resourcing
ChemPharm offers flexible resourcing solutions to meet your specific needs. Our services include providing remote support teams, deploying experts to your CMO’s site as your "man in the plant," and integrating seamlessly with your current team at your site. This ensures that you have the right expertise and support, wherever and whenever you need it, to achieve your project goals efficiently and effectively.