Blog Post Consumer Products Food and Beverage Food Safety and Recalls: Emerging Regulations Governing US Based Food Companies The FDA’s 2011 Food Safety Modernization Act (FSMA) has been transforming the U.S. food safety system, with ongoing implementation creating ...
Blog Post Biotech Quality + Compliance What is the Future of Liquid Biopsy Diagnosis? The promising outlook for liquid biopsy diagnosis has sparked the interest of many in the biotech industry. The speed, ease, ...
Blog Post Research + Development Consulting Services Stepping Away from Convention in Clinical Trial Design Clinical trial design, like much of the industry, is experiencing a wave of innovation and disruption. Classical randomized control trials ...
Blog Post Food and Beverage Information Technology HACCP in the 21st Century Even after the introduction of HARPC (Hazard Analysis and Risk-Based Preventive Controls) under the FSMA (Food Safety Modernization Act), the ...
Blog Post Generics Quality + Compliance The State of Biosimilars in the U.S. The global market for biosimilars is estimated to reach $15 billion by 2020 or 2021. While in Europe biosimilars have ...
Blog Post Quality + Compliance Consulting Services How Realistic is the U.S. Importation of Canadian Drugs? On July 31, 2019, the White House announced an iterative healthcare plan that would allow the importation of Canadian drugs ...
Blog Post Consumer Products Health and Beauty How Close Are We to Updated Cosmetics Regulations? Health and wellness continues to gather momentum as a prominent focus of the mainstream consumer, and the movement shows no ...
Case Study Biotech Consulting Services Veeva Vault QualityDocs and RIMS Implementation For several years, trends in modern medicine have been shifting towards promising treatments in cell and gene therapy. Backing these ...
Blog Post Medical Device Consulting Services How the Medical Device Tax Affects Your Business Even though the medical device tax was passed in 2012 as a part of the Patient Protection and Affordable Care ...
Blog Post Quality + Compliance Consumer Products The True Costs of Trade Tariffs to Your CPG Business As trade disputes between the United States and China escalate, both countries recently expanded their import tariffs for the second ...
Blog Post Medical Device Information Technology What Does the FDA Think About AI in Medical Device? The FDA has welcomed the use of AI in medical devices, as evidenced by the former commissioner’s optimistic attitude about ...
Blog Post Consulting Services Pharma What Does Scott Gottlieb’s Exit Mean for the Industry? In March, FDA commissioner Scott Gottlieb announced his resignation, which became effective last Friday, April 5th. Highly regarded by life ...
