Rochem’s Regulatory group ensures that all Pharmaceutical, Nutritional, and Food products meet their applicable monograph/standard (USP/NF/EP/FCC) ensuring that all methodology/specifications are in compliance with the current applicable monograph and products are labeled correctly.
Rochem’s Regulatory group has the expertise to file and maintain Drug Master Files and Certificates of Suitability (COS) in virtually any regulated market.
Regulatory submissions filed by Rochem are prepared by our U.S. and Qingdao, China based Regulatory teams in coordination with product manufacturers. This ensures the most accurate and technically sound submission possible.
All DMF/COS submissions are filed in Common Technical Document (CTD) format. Rochem’s expert regulatory group has the capability of filing electronic DMFs (eCTD) to support the fastest approval possible for our customers.
Our close relationships with our represented manufacturers allows us to respond quickly and accurately in all aspects of regulatory submissions.
The experience of our Regulatory staff and good working relationship with the FDA, enables Rochem to address Regulatory issues and expedite regulatory approvals quickly.
Rochem’s Regulatory group ensures that all USP Pharmaceutical products meet their corresponding OTC monograph.
Rochem subscribes to all major monographs as well as their corresponding forums. This allows Rochem to ensure manufacturers are working toward full monograph compliance when a new or revised monograph is proposed. Rochem also ensures that manufacturers stay well informed of changes and the introductions of new general chapter monographs.
Our technical support services include, but are not limited to, the following:
Full project management from product conception to commercialization
Manufacturing process and product quality optimization
Analytical support and problem solving
Customer technical queries and requests
Establishment of manufacturer product specifications