About
PharmaLex offers specialized consulting services for the pharmaceutical, biotech, and medical device industries. Their focus on compliance ensures that clients navigate regulations with confidence. With a team of experts, including former FDA and EMA professionals, they provide knowledge through blogs, webinars, and articles. Clients range from top pharmaceutical companies to small to medium-sized enterprises, demonstrating their capability to deliver high satisfaction across diverse needs in the industry. Their initiatives emphasize education, empowerment, inclusivity, and sustainability, enhancing the overall impact of their services.
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Rook Quality Systems provides quality systems and regulatory consulting services for medical device companies, supporting class I–III devices including SaMD and IVDs. The firm offers tailored Quality Management System (QMS) development and implementation, Design History Files (DHF) and Technical Files (TF) support, and audit support for FDA, Notified Body, and MDSAP audits. Rook lists expertise in FDA regulations, ISO 13485:2016, ISO 14971, MDR/IVDR conformity, 21 CFR 820, 510(k) submissions, Design Control, Risk Management, CAPA, complaint handling, supplier approval, verification and validation. The company also develops customized quality training and assists with international product registration and post-market monitoring for medical device clients.
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Techmedics is an IT support and managed services company that offers managed IT services, managed support, cloud solutions and infrastructure for businesses. The firm presents a model with a dedicated IT team and a predictable monthly fee. Techmedics states it helps keep systems reliable and data protected, and supports businesses across multiple US cities including Los Angeles, Dallas, Denver, Phoenix and Las Vegas. The site positions the company as delivering scalable IT services for organizations of varied size and industry and references 25 years of industry experience. The record also references governance, risk and compliance (GRC) as an area of service interest.
