During the clinical research stage of new drug development, the quality and reliability of research materials are very important. The human absorption, distribution, metabolism and excretion (ADME) studies using 14C-labeled active pharmaceutical ingredients (APIs) are an essential component when submitting applications to regulatory authorities such as the FDA and EMA. The purity and stability of the radiolabeled compounds are the impact factors for the success of these critical studies.
GMP Services
Amerigo Scientific offers comprehensive services for the manufacture of 14C-labeled APIs. With extensive expertise in radiochemistry and advanced facilities, our services strictly adhere to the Good Manufacturing Practice (GMP) guidelines to ensure that 14C-labeled compounds have high quality and regulatory compliance. Our mission is to provide reliable 14C-labeled APIs and data to advance through clinical trials.
Why Choose Our Services
Every step from synthesis to storage strictly adheres to ICH guidelines to ensure that our clients receive 14C-labeled APIs that comply with relevant regulations. Our GMP services, such as radiolabel synthesis, purification, and analysis, are performed in compliance with ICH Q7 Section 19.
The analytical data for GMP campaigns are generated using equipment from Agilent, RIS Science, Thermo Fisher, and Mettler Toledo, and are stored using data solutions that comply with 21 CFR Part 11. These data integrity compliance solutions are integrated throughout state-of-the-art facilities, including four ISO 7 clean rooms and a well-equipped quality control laboratory.
- GMP and Regulatory Excellence: Amerigo Scientific provides GMP manufacturing and related services, ensuring every product meets quality standards and client requirements. Our processes and SOPs are continually updated per the latest regulatory guidance.
- Advanced Facilities and Expertise: With advanced instruments and extensive experience, we are confident that we can efficiently complete complex synthesis processes.
- Comprehensive Data Package: Every delivery includes a complete data package suitable for regulatory submission, including spectroscopic data, chromatograms, stability data, and a signed Certificate of Analysis.
- Client-centered Support: Throughout the entire process, we maintain open communication and always adhere to the principle of transparency. Our clients' success is our success, and therefore we go the extra mile to achieve it.
Collaboration with Us
Initiate Discussions
We are more than willing to evaluate the project needs of your team, or to have discussions regarding our GMP capabilities and facilities. Please contact us and our professional proposal development coordinator will discuss your project with you.
Proposal Generation
Radiochemistry experts and proposal development coordinator will collaborate with you to design an efficient GMP 14C-labeled API manufacturing plan, with the scope of the plan meeting regulatory requirements. We will regularly review the key elements of the plan to ensure that results meet the needs and expectations of your team.
Quality Assurance
We welcome clients to conduct audits of the quality system and facilities, whether on-site or remote.
During the GMP Service Period
A dedicated project manager will work with your team to provide comprehensive project coordination and logistical support to facilitate the successful completion of the service.
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