DMF Review and Submission Our staff has over 20 years experience compiling, reviewing, submitting, and supporting major company's DMFs including ACS Dobfar and Farchemia (Italy), Fermion and Leiras (Finland), Justesa and Moehs (Spain), Seloc (France), Sifa (Ireland & Switzerland), Tessenderlo (Brussels), Uquifa (Barcelona) and others. Format, Assembly, and Acceptance by the FDA Betterchem's reviewers help ensure that DMF holders retain a complete reference copy that is identical to, and maintained in the same chronological order as, their submissions to FDA. DMFs will be reviewed to determine whether the documentation agrees with actual manufacturing and controls practices. DMF Letters of Authorization Our staff reviews the DMF holder's letters of authorization for dates, names, product references, statements of commitment, and signatures.       DMF Format, Content, and CMC Review The fact that the FDA acknowledges and assigns a DMF number simply means that the submission is administratively acceptable. Our staff not only ensures that your DMFs meet the FDA's requirements for format and content, they perform detailed reviews to determine regulatory compliance. They also coordinate cGMP activities and review the chemistry, manufacturing, and controls required by all supported market applications. DMF Deficiencies Our reviewers respond quickly when a DMF holder receives letters from the FDA describing DMF deficiencies. We also coordinate FDA's notification of persons relying on the information in the DMF that additional information is needed. Changes to a DMF Betterchem reviewers help strengthen the DMF holder's policy regarding DMF changes, additions, or deletions. This includes changes in authorization related to specific customers. Listing of Persons Authorized to Refer to a Drug Master File Betterchem works with your DMF staff to maintain and update the required list of persons authorized to incorporate information in the DMF by reference under 21 CFR 314.420. Annual Updates Our reviewers coordinate activities to ensure that the holder has sufficiently updated the DMF or assured the FDA that previously submitted material and lists in the DMF remain current. Notification of Intent to Reorganize or Close a DMF We help build a strong policy regarding major changes that could negatively affect the supported market applications. This includes transfer of ownership and file closure. cGMP Audits: Details

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