The pharmaceutical industry has evolved considerably from traditional dosage form manufacturing methods to its current status as a cost-effective, efficient, modern innovator of science, business, and technology. This dynamic industry sector – rooted in traditional and long-standing regulatory oversight – faces unique challenges, in the form of continually evolving – and increasing – approaches to manufacturing quality and compliance risk tolerance from government regulators. After fifty-plus years of current good manufacturing practice (cGMP) regulation, FDA and other international regulators have little tolerance for a pharmaceutical company’s non-conforming GMP practices.
Compliance Architects' Industry Experts
Compliance Architects’ industry experts have extensive manufacturing, quality, development, validation and related experience – from the plant-floor to the C-suite – and have been immersed in the pharmaceutical industry for decades.
Compliance Architects is uniquely positioned to provide innovative business-supportive solutions, grounded in regulatory compliance, that will improve product quality and as a result, patient outcomes. Compliance Architects is the proven consulting partner for some of the industry’s largest and most trusted pharmaceutical manufacturing organizations.