Cyctek Inc. is proud to provide guidance on Health Canada Natural and Non‐prescription Health Products GMP Site Licensing and Product licensing. Our specialty is on complicated product licensing that requires supporting literature research and clinical studies to the support of the product claims. We have access to extensive research resources and able to help our customers in product development and licensing.
Our experienced consultant team provides 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).
Cyctek consulting 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, QMS design, SOP drafting, change management and audit consulting.
Cyctek consulting team is experienced with ISO 9001:2015 QMS certification in Canada. We can help organizations prepare for and obtain federal government standard certification. Our team can guide you on the eight phases of certification processes and develop your team to be self-sufficient in the maintenance of your Quality Management System.
Our consulting team is also experienced in food quality management with in‐depth HACCP and GFSI knowledge. We have also performed Canada Cosmetic products importation training and registration.