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Managing Regulatory Compliance for Abbreviated New Drug Applications

The regulatory approval pathway for Abbreviated New Drug Applications (ANDAs) is relatively complex, involving significant investment of money and time. ANDA applicants must ensure they meet the stringent requirements set by the US FDA. Minor mistakes can lead to ‘Refusal to Receive’ (RTR) which can pose a significant cost burden to the company and delay the approval process. Not only must ANDA applicants make sure they maintain regulatory compliance, but they also must ensure their outsourced facilities, including manufacturing sites, are compliant with applicable regulations. Therefore, it is important for ANDA applicants to communicate with the US FDA throughout the entire ANDA filing process for any clarifications- from product development to approval stages. Moreover, foreign companies that are looking to obtain approval from the US FDA must also appoint a US Agent to support them with the ANDA process. US Agents play an important role in facilitating communication between the foreign companies and the US FDA for ANDA filings.

Strategic Partnership for Marketing Authorization Holder Services

In the European Union (EU), companies looking to obtain marketing authorization (MA) from the European Medicines Agency (EMA) for their products must make sure they adhere to EMA’s stringent requirements. MA holders must ensure that they, and other facilities involved in the MA approval process, comply with EU legislations and guidelines. Furthermore, to stay ahead of regulatory hurdles and gain a significant market share within the European Union, pharmaceutical companies are looking to partner with EU local entities, with robust knowledge and experience of the EU market, that can hold the MA on behalf of them. From a business and operational perspective, having a local presence in one EU Member State allows pharmaceutical companies to manage and distribute their products across the entire EU region. It also enables a clear communication channel with EMA and Competent Authorities (CAs) of Member States. This strategic partnership helps to ensure compliance with EU regulations to obtain timely MA approvals and manage product lifecycle throughout the region.

Similarly, the ASEAN region presents global pharmaceutical companies a lucrative opportunity, due to its expanding healthcare and harmonized regulatory processes, to bring their products to the ASEAN market. Global companies are looking for on-ground presence in the form of representative offices in the ASEAN region to support them with MA holding (including registration certificate holding) and carrying out the necessary activities for regulatory compliance. This supports global pharmaceutical companies in further sale of their products into the South-East Asian territories.

DDReg’s ANDA and MA Holder Services

Given the multiple challenges surrounding ANDA filings and obtaining regulatory approval , pharmaceutical companies prefer to partner with experts that bring technical experience and local infrastructure to support seamless ANDA filings. DDReg Pharma Inc. in Delaware, USA is verified by the US FDA to carry out abbreviated new drug application (ANDA) services for its customers. Through its local US Agent support, DDReg can facilitate communication & correspondence with the US FDA, schedule pre-submission meetings, submit citizen petitions, and enable GMP audits/inspections. DDReg has supported its customers with ANDA services and have held ANDAs on behalf of pharmaceutical companies for ANDA submissions, obtaining timely approvals, and handling post-approval lifecycle management.

In Europe, DDReg Pharma GmbH, in Köln, Germany allows DDReg to provide marketing authorization (MA) holder services to pharmaceutical companies to take on the responsibilities and duties of MAHs for the required time period. The MAH services provided by DDReg has supported customers who wish to penetrate the European market as non-EU Member States and those that require a GMP-compliant Pharmacovigilance (PV) and quality management system (QMS). DDReg has also supported pharmaceutical companies looking to obtain MA, particularly through mutual recognition procedure (MRP) and decentralized procedure (DP) through external MAHs, and additional services including Qualified Person for Pharmacovigilance (QPPV).

DDReg’s Global Presence

In addition to EU & US offices to support with MA & ANDA requirements, DDReg Singapore and Dubai offices support its global customers looking to penetrate the lucrative ASEAN & GCC market. It provides them with in-depth technical & subject matter expertise coupled with local presence to penetrate the South-East Asian and Gulf territories while maintaining regulatory compliance.

Our capabilities include:

  • LTR Services
  • RTR Due Diligence for ANDAs
  • Due diligence of business validation rejection criteria- UK,EU, MOHAP, Saudi FDA, Jordan, Lebanon, Algeria, Morocco,etc.
  • LQPPV Services for ASEAN, GCC, Africa, LatAm, CIS, UK & EU
How can we help you?
Call us on:+1 (302) 601-2755
Contact our experts today !
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