Marketing Authorization Holder Services
We at DDReg help our customers hold Marketing Authorizations (MAs) on their behalf across various geographies. We have extensive experience of holding Abbreviated New Drug Applications (ANDAs) in the US as well as MAs in EU, ASEAN, LATAM and GCC regions. Specifically, for ANDAs, we ensure regulatory compliance by way of annual reports or Drug Safety compliance for efficient management of your abbreviated new drug application.
DISCOVER MOREANDA Regulatory Support
The pathway for abbreviated new drug applications is complex and resource-intensive. ANDA applicants must adhere to the stringent requirements set by the US FDA, where even minor errors can trigger a ‘Refusal to Receive’ (RTR) and cause costly delays. Our ANDA Consulting Services guide you through every step of the ANDA Submission process, ensuring your documentation and outsourced facilities meet all regulatory requirements.
“In addition to regulatory consulting, DDReg offers ANDA Holding services, providing companies without a US presence the opportunity to maintain their ANDA filings through our verified US affiliates. This ensures alignment with FDA regulations while enabling faster market access.”
With dedicated support from our verified US team, we facilitate communication with the US FDA through scheduled pre-submission meetings, citizen petition submissions, and GMP audits. Our expertise in handling an abbreviated new drug application minimizes errors and streamlines your regulatory approval process, safeguarding your investment of time and money.
Strategic Marketing Authorization Holder (MAH) Services
In the European Union, obtaining marketing authorization requires strict compliance with EMA guidelines. Our MAH Service is designed to support companies in fulfilling these rigorous requirements. By partnering with local EU entities, we ensure that your facilities and operations meet all necessary regulations, facilitating clear communication with the EMA and Competent Authorities.
Beyond the EU, our global presence in ASEAN, LATAM and GCC markets provides additional strategic advantages. With offices in Singapore and Germany, we support companies seeking local representation and regulatory guidance, ensuring that your marketing authorization is managed efficiently across diverse territories.
Our ANDA & MA Holding Expertise
- MA/ANDA Holding Services
- MA transfer and retention
- Handling and dossier communication with drug authorities
- Maintaining updated registration records and renewal
- Pre-screening of dossier before submission as per agency requirements
- Application generation for dossier submission
- LTR Services
- RTR Due Diligence for ANDAs
- Due Diligence of Business Validation Rejection Criteria (UK, EU, MOHAP, Saudi FDA, Jordan, Lebanon, Algeria, Morocco, etc.)
Ready to streamline your ANDA Submission and secure efficient MA Holder Services?