North America Health Investment Group Inc. is capable of providing expert guidance on Health Canada Natural and Non‐prescription Health Products GMP Site Licensing and Product licensing. Our professional services team has the successful experience of obtaining over fifty NHPD site licenses approval for Canadian and Foreign sites. Our specialty is on complicated product licensing that requires supporting literature research and clinical studies for the support of the product claims.
Our experienced consultants provide GMP guidance, training, translation services, submission coordination, Standard Operating Procedure (SOP) design and review, Standard Operating Record (SOR) design and filing, and product licensing research on Traditional Chinese Medicine within or outside the Chinese Pharmacopeia. Our internally developed licensing process is designed for all foreign sites as it includes standard questionnaire and document list, ensuring fast preparation and quick turnover. We also can help companies perform product monitoring in documentation including product Periodic Benefit‐Risk Evaluation Report (PBRER), Periodic Safety Update report (PSUR) and Annual Summary Report (ASR).
North America Health consultant team has expertise in ISO13485 certification, Medical Device Establishment Licenses (MDEL) and its audit with Health Canada in hardware and software based medical devices. We can provide Internal audit services, SOP design and change management and audit consulting.
North America Health consultant team also is experienced with ISO 9001:2015 QMS certification in Canada. We can help an organization prepare for and obtain federal government recognized certification. Our team will guide you on the eight phases of certification processes and develop your team to be self-sufficient in the Quality Management System.
Our consultant team is also experienced in food quality management with in‐depth HACCP knowledge. We have also performed Canada Cosmetic products importing training and registration.