Biologics Consulting Group

BCG provides professional services to help clients efficiently handle the complex regulatory procedures that can arise during the medical device product renewal process. We support the entire process, including preparing required documents, reviewing and supplementing technical documentation according to regulatory requirements, preparing and submitting renewal applications, and responding to audits. Additionally, we ensure that the latest regulatory requirements and updated laws are incorporated into the renewal process, ensuring that the product continues to comply with regulations. Specifically, we review data related to the safety and efficacy of the product and assist in preparing additional materials if necessary for the renewal approval. BCG's product renewal service offers systematic and professional support to help importers and manufacturers avoid risks related to expired licenses and maintain ongoing competitiveness in the market.