FDA Regulatory Compliance Consulting
The Federal Code of Regulations, Title 21, known as 21CFR, is a comprehensive body of law comprised of the Food and Drug Acts and ICH (c)GMP technical requirements that govern the manufacture and import of substances into the United States. The Food and Drug Administration is tasked with maintaining and enforcing the manufacturing, registration, labeling and import requirements created in 21CFR with the goal of securing the quality, efficacy and safety of all approved and registered substances that are marketed or imported into the U.S.
Saxon Interglobal Associates can help you navigate the challenging world of 21CFR guidance and the FDA's dynamic implementation process delivered over 21st century information technology. We can help uncover your firm's Regulatory Compliance requirements, and assist you with 21CFR Regulatory Compliance strategies that optimize cost reduction and efficiency. SIA can offer your firm the advantage of comprehensive, reliable, and competitive services to meet or exceed your compliance goals.
Saxon Interglobal Associates offers FDA Regulatory Compliance Consulting assistance in the following areas:
-FDA Regulatory Intelligence
-Global Regulatory Strategies
-FDA Regulatory Agency Communication Facilitation
-FDA Submissions Planning and Project Management
-HL7-SPL and eCTD Submissions Requirements
The Federal Code of Regulations, Title 21, known as 21CFR, is a comprehensive body of law comprised of the Food and Drug Acts and ICH (c)GMP technical requirements that govern the manufacture and import of substances into the United States. The Food and Drug Administration is tasked with maintaining and enforcing the manufacturing, registration, labeling and import requirements created in 21CFR with the goal of securing the quality, efficacy and safety of all approved and registered substances that are marketed or imported into the U.S.
Saxon Interglobal Associates can help you navigate the challenging world of 21CFR guidance and the FDA's dynamic implementation process delivered over 21st century information technology. We can help uncover your firm's Regulatory Compliance requirements, and assist you with 21CFR Regulatory Compliance strategies that optimize cost reduction and efficiency. SIA can offer your firm the advantage of comprehensive, reliable, and competitive services to meet or exceed your compliance goals.
Saxon Interglobal Associates offers FDA Regulatory Compliance Consulting assistance in the following areas:
-FDA Regulatory Intelligence
-Global Regulatory Strategies
-FDA Regulatory Agency Communication Facilitation
-FDA Submissions Planning and Project Management
-HL7-SPL and eCTD Submissions Requirements