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Type II DMF Drafting, Review, and Verification
Your company can now have guidance and prototypes for each section of a Type II DMF leading to chemistry and regulatory review by leading API experts.
DMF and data are handled in a manner consistent with FDA chemistry reviews. Reporting discrepancies are corrected and the core systems are improved using appropriate change control procedures. Your staff increases their cGMP understanding and compliance as your company moves forward toward success in the US market.
USActives also reviews data for compliance with pharmacopeial (USP) and end-user standards. Revised information is integrated into subsequent DMF drafts until USActives is confident that the FDA will give the project a green light.
The DMF compilation, review, and verification phase often takes more than 3 months to complete. If significant deficiencies are found, USActives will recommend strategies to continue the DMF revision while protocols and/or tests are revised and new data are generated.
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DMF Submission to the FDA
The final review and submission of the DMF to the FDA should take approximately 2 weeks. Letters of Authorization, DMF maintenance, and the transfer of technical information to prospective customers occurs on a continuous basis.
API Commercialization
API commercialization requires the transfer of technical documents and research and development (R&D) quantities of the API for testing and qualification by prospective customers. USActives assists the API manufacturer during this R&D phase and will recommend format and content of the necessary documentation. The company also coordinates the transfer of extra-pharmacopeial specifications established by each customer. This work is carried out on an "as needed" basis.
Introducing… USActives
Our new company's 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.
Manufacturers that do not currently have a US agent are encouraged to contact our staff for guidance. Avoid those US sales agents that add unreasonable fees and/or commissions for DMF related services. Affordable, competent representation is within reach.
cGMP Audit Outline
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