What are CEP, DMF & ASMF Filing Services?
Our services include preparation of Type I-V DMF dossiers, CEP applications, ASMF filings, and lifecycle management, ensuring global regulatory compliance for pharmaceutical submissions.
CEP, DMF & ASMF Filings for Global Compliance
Streamlined Regulatory Support for Market Access
At Indivirtus Healthcare Services Pvt. Ltd., our CEP, DMF, and ASMF Filing services provide end-to-end support for pharmaceutical manufacturers. We manage Type I-V DMF dossiers, CEP submissions to EDQM, and ASMF filings for EU markets, ensuring regulatory compliance and seamless market authorization across global territories.
Why is it Critical?
Compliant CEP, DMF, and ASMF filings ensure regulatory approval, data integrity, and market access, minimizing delays in global pharmaceutical submissions.
Our Role in Your Success
As a trusted CRO, Indivirtus Healthcare Services delivers expert-led filing solutions, providing accurate, regulator-ready submissions to support seamless market entry.
Our Expert Filing Approach
At Indivirtus Healthcare Services, our CEP, DMF, and ASMF Filing services are led by certified regulatory experts with global compliance expertise. We prepare comprehensive Type I-V DMF dossiers, CEP applications for EDQM, and ASMF filings for EU markets, managing updates, gap closures, and post-approval variations.
Our structured approach ensures submission-ready documentation, aligning with ICH M4, EU EMA ASMF guidance, EDQM certification procedures, and US FDA DMF requirements for efficient regulatory approvals.
CEP, DMF & ASMF Deliverables
DMF (Type I-V) Dossier: Comprehensive documentation for API and product submissions.
CEP Application with Supporting Modules: Submission-ready documents for EDQM certification.
ASMF for EU Compliance: Active Substance Master File for European market authorization.
Lifecycle Management Documentation: Updates and variations for ongoing compliance.
Regulatory Compliance & Global Standards
Our CEP, DMF, and ASMF Filing services align with stringent global standards, ensuring your submissions are regulator-ready and compliant with international markets. By adhering to industry-leading guidelines, we deliver solutions that enhance approval success.
- ICH M4 Guidelines: Global standards for Common Technical Document structure.
- EU EMA ASMF Guidance: European standards for Active Substance Master File submissions.
- EDQM Certification Procedures: Standards for Certificate of Suitability (CEP) filings.
- US FDA DMF Filing Requirements: U.S. regulations for Drug Master File submissions.
Applications & Use Cases
Our CEP, DMF, and ASMF Filing services are essential for pharmaceutical manufacturers seeking global market authorization. Ideal for API and finished product submissions, our solutions support regulatory compliance across US, EU, and other markets. Key use cases include preparing DMFs for generics, CEPs for APIs, and ASMFs for EU submissions.
Why Choose Indivirtus Healthcare
Indivirtus Healthcare Services is a trusted partner for pharmaceutical manufacturers, delivering expert-led filing solutions backed by certified regulatory professionals with global experience. Our services ensure scientifically defensible outcomes, rapid delivery, and strict confidentiality to protect your proprietary information.
With a commitment to industry best practices, we empower your organization with compliant, efficient filing processes, driving regulatory success and market access.
Frequently Asked Questions
Frequently Asked Questions
What is a DMF and why is it important?
A Drug Master File (DMF) is a regulatory document submitted to agencies like the US FDA to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of drugs. It supports the approval of generic and branded drugs.
What is the difference between a DMF and CEP?
A DMF is submitted to individual regulatory authorities like the US FDA, while a CEP (Certificate of Suitability) is issued by the EDQM in Europe and certifies that the quality of a substance complies with European Pharmacopoeia standards.
What is included in a CEP submission?
A CEP submission includes detailed quality documentation (including modules 2 and 3), manufacturing process, analytical methods, impurity profile, stability data, and GMP compliance information for assessment by the EDQM.
Can you help with ASMF preparation for Europe?
Yes, we provide complete ASMF development including Applicant's Part and Restricted Part, ensuring alignment with EMA guidance for EU filings and centralized or decentralized submissions.
Do you offer lifecycle support after submission?
Yes, our team provides post-submission lifecycle support such as variation filing, renewal management, and addressing queries raised by regulatory agencies for CEP/DMF/ASMF documentation.
What do CEP, DMF, and ASMF Filing services include?
Our services include preparation of Type I-V DMF dossiers, CEP applications, ASMF filings, and lifecycle management for global regulatory compliance.
Who benefits from CEP, DMF, and ASMF Filing services?
Pharmaceutical manufacturers seeking market authorization for APIs or finished products in US, EU, and other markets benefit from our tailored solutions.
How do these services ensure regulatory compliance?
Our services align with ICH M4, EU EMA ASMF guidance, EDQM certification procedures, and US FDA DMF requirements, ensuring global compliance.
What deliverables are provided with the service?
Clients receive DMF dossiers, CEP applications, ASMF filings, and lifecycle management documentation.
Can the filing services be customized for our needs?
Yes, our services are tailored to your specific product, market, and regulatory requirements, ensuring compliant and effective filings.
How do the services support global market entry?
We prepare compliant DMF, CEP, and ASMF submissions, manage updates, and address gaps to ensure seamless approvals across global markets.