FAQs

Yes, we offer a full range of Good Clinical Practice (GCP), Good Documentation Practices (GDP), and Good Manufacturing Practice (GMP). The Landrich Group also offers training for other relevant topics like Design Control, Risk Management, and Usability Engineering.

Landrich Group provides a wide range of expert consulting services to support medical device, IVD, and pharmaceutical companies throughout the product lifecycle. Our core capabilities include: Clinical Services (CRO) – Full-service clinical trial management and monitoring. Quality Assurance – Offering QMS gap assessments, QMS implementation, FDA, EU and other region inspection readiness support. Regulatory Affairs – Regulatory guidance and strategy (e.g., FDA, EU MDR/IVDR, etc.), pre-sub meetings, submissions, and post-market support. regulatory guidance. Quality Management – Design, implementation, and auditing of QMS. U.S. Agent Services – Acting as U.S. Agent for foreign manufacturers to coordinate communications with the FDA to ensure regulatory compliance. GCP/GMP Training – Custom training programs on Good Clinical/Manufacturing Practices. SOP Development – Creating and optimizing Standard Operating Procedures. Biostatistics – Statistical planning, analysis, and reporting for clinical studies. Data Management – Clinical data handling, validation, and reporting. R&D Support – Technical, quality and regulatory assistance for analytical and clinical performance evaluation studies during product development. We tailor our services to meet your specific needs, from early-stage development to post-market support.

Landrich Group works with companies of all sizes, from startups to large enterprises. We provide tailored solutions to meet the unique needs of emerging biotech and pharmaceutical startups, as well as established organizations. Our team offers strategic guidance, regulatory support, clinical trial management, and training services to help startups navigate complex industry regulations and accelerate growth, while also supporting large companies with scalable and efficient solutions.

Yes, Landrich Group provides comprehensive clinical study management services as a Contract Research Organization (CRO). Our team supports every stage of the clinical trial process, including study design, regulatory submissions, site selection, patient recruitment, data management, and compliance with GCP guidelines. We work closely with sponsors to ensure efficient trial execution, regulatory adherence, and high-quality results to support drug and medical device development.