Industries
We provide you turn-key project in the regulated industry space.
Startups & New Ventures
For startups seeking FDA or EU approvals, we provide comprehensive consultations. Our services encompass initial startup costs, ongoing maintenance expenses, and precise estimations of approval timelines. We are dedicated to supporting your startup's regulatory journey from inception to success.
Medical Devices And Combo Products
Our specialized guidance addresses the complexities of medical devices and combination products. We offer comprehensive support to assist you in navigating the regulatory landscape and achieving success in medical device domains.
Biotech and Pharmaceutical Industries
Extending our services to both the pharmaceutical and biotech sectors, we provide comprehensive support, including regulatory compliance, validation, data integrity, audit, and QMS assistance. As your trusted partner, we ensure excellence in navigating the intricacies of these highly regulated industries.
Clinical Research
Specializing in Phases 0 to 4, our consultancy offers expertise in CDMO, CRO, and CTL auditing. Additionally, we provide internal support, training monitors, and CRO staff to ensure successful study protocol execution.
Beverage and Food
Our consulting services specialize in guiding food and beverage companies to achieve compliance with key regulations. We address CFR Part 117, Part 11, cGMP, FSMA, ISO standards (including 14001, FSSC 22000, 18001/45001, and 31000), as well as USDA QMP and QAD requirements.
Dietary Supplements
From facility selection to comprehensive commercial marketing support, we provide a full spectrum of services to support your dietary supplement venture. With our expertise, we ensure a seamless journey from initial planning to market success.