API and DMF Services
Drug Master Files (DMFs) contain confidential and detailed information regarding API processes—from manufacturing to storage. DDReg’s DMF Services deliver precise, confidential, and detailed insights from manufacturing to storage. With our expert guidance, every file is meticulously prepared to meet the highest regulatory standards.
DISCOVER MOREYour Trusted Partner in DMF Submissions
DDReg experts assist with Certificate of Suitability (CEP), referenced in Marketing Authorization Applications after European Directorate for the Quality of Medicines & Healthcare (EDQM) approval, an API dossier detailing ingredient properties and manufacturing processes ensuring that your product stands out in competitive European markets.
We extend our expertise to Active Substance Master File (ASMF) submissions, offering comprehensive US FDA DMF services, European regulatory support, and specialized assistance with CADIFA submissions in Brazil. By delivering detailed yield calculations and process insights, we empower our clients with the data needed to achieve regulatory success across multiple jurisdictions.
DDReg provides expert regulatory consulting and efficient services for drug substance submissions for the US, EU, Brazil, and other regions. Our experience includes handling Certificate of Suitability (CEP/COS) submissions to the European Directorate for the Quality of Medicines & Healthcare (EDQM), Drug Master Files (DMFs), Active Substance Master Files (ASMFs), and CADIFA dossiers—ensuring regulatory compliance and streamlined market access.
Basics of DMF Services for Active Pharmaceutical Ingredients
DMF Services for Active Pharmaceutical Ingredients (APIs) are vital for ensuring drug safety. DMFs provide a comprehensive repository of detailed information regarding the manufacturing, processing, and testing of APIs. This transparency supports effective communication between API manufacturers and regulatory authorities, helping to mitigate risks associated with drug production.
Pharmaceutical organizations submit Drug Master Files Pharma to provide confidential insights into the manufacturing, quality, and safety of their products. This process, supported by our expert DMF Consultants, ensures regulatory compliance and streamlines approval processes.
With an unwavering commitment to regulatory excellence, DDReg streamlines the process, offering advanced support through every step—from initial document drafting to final submission and beyond.
Our API and DMF Expertise
DDReg is committed to elevating your regulatory strategy with our specialized DMF validation and expert consultancy. We offer a full suite of services tailored to your unique needs, ensuring your submissions are robust and reliable.
- Expert writing and submission of ASMF, DMF, CEP, and CADIFA modules
- Comprehensive due diligence for ASMF, DMF, CEP, and CADIFA dossiers
- In-depth API documentation audits
- Seamless conversion from CTD/Paper to eCTD format
- Custom module writing for both open and restricted sections of ASMF/DMF for APIs, intermediates, and semi-finished dosage units
- Preparation of Module 1, 2, and 3 for CEP dossiers ensuring stringent quality checks
- API CTD compilation, digital publishing in eCTD, and efficient submission processes
- Expert assistance in responding to agency queries with precision and clarity
Our integrated approach combines proven DMF Submissions techniques with expert guidance from seasoned DMF Consultants, ensuring every detail is compliant and strategically positioned.