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NDA Submissions Support

When a pharmaceutical company develops a new drug and want to be approved for sales and marketing, it must submit new drug application (NDA) to the regulatory authorities, such as the Food and Drug Administration (FDA) in the United States. The submission will undergo a rigorous review process by the regulatory authorities to determine if the drug is safe and effective for its intended use. The NDA includes detailed information on the drug's safety, efficacy, manufacturing process, and labeling, and require thorough preparation and planning to ensure compliance with regulatory requirements and to increase the likelihood of approval. However, it is a time-consuming and complex process that requires expertise and precision to ensure successful approval. At our company, we offer a comprehensive NDA submissions service to pharmaceutical companies looking to bring their new drugs to market. Our team of experts has years of experience in preparing and submitting NDAs to regulatory authorities around the world. We are well-versed in the regulatory requirements and guidelines, ensuring that your NDA is submitted accurately and efficiently.

Our NDA Submissions Service

Our service offers comprehensive support to pharmaceutical companies in preparing and submitting NDAs. We have a team of regulatory experts who are experienced in navigating the regulatory pathway of NDA Submissions and can provide guidance and assistance throughout the submission process. Our services include:

Strategic Support in Identifying the Optimal Regulatory Pathway for NDA Submission

By understanding the specific needs and characteristics of each drug candidate, we can help determine the best route to ensure a successful and efficient approval process.

Pre-Submission Meeting Support

We offer pre-submission meeting support, including the preparation of briefing packages and representing our clients in meetings with regulatory authorities. These meetings offer a valuable opportunity to discuss scientific issues related to the NDA filing and address any potential concerns early in the process.

NDA Templates and eCTD Submissions

Our team provides NDA templates with detailed technical information to facilitate the preparation of comprehensive NDA submissions. We also support clients in the submission of electronic Common Technical Document (eCTD) applications, ensuring compliance with regulatory requirements for electronic submissions.

Regulatory Response Strategy

We assist our clients in developing effective regulatory response strategies and preparing timely responses to queries and information requests from the regulatory agencies.

Gap Analysis and Risk Mitigation

We conduct comprehensive gap analyses of developmental data and source data against NDA submission requirements, identifying potential regulatory gaps. We work closely with customers to develop risk mitigation plans and address any deficiencies to enhance the likelihood of successful NDA approval.

Preparation of NDA Documents

We will assist you in compiling the necessary data and documentation required for the NDA submission, including clinical trial data, safety information, and manufacturing details.

Pre- and Post-Submission Regulatory Support

Our team provides ongoing regulatory support for pre- and post-submission interactions with the regulatory agencies, guiding clients through the NDA approval program. We assist in navigating regulatory processes, addressing inquiries, and facilitating communication with regulatory authorities.

NDA Post-Approval Lifecycle Management

We offer support in managing the post-approval lifecycle of NDAs, including compliance requirements, labeling updates, post-marketing surveillance activities, supplements, annual reports, etc.

Complete Response Letter (CRL) Management

In the event of receiving a Complete Response Letter (CRL) for an NDA, we provide strategic guidance and submission support to address the regulatory authorities' concerns and facilitate the approval process. Our experienced team assists in preparing comprehensive responses to CRLs to expedite the approval process.

Our Advantages

Expertise: Our team of experts has in-depth knowledge of regulatory requirements and guidelines, ensuring that your NDA is prepared accurately and submitted efficiently.
Efficiency: We understand the complexities of the NDA submission process and can help streamline the process to ensure timely approval.
Compliance: We are committed to ensuring that your NDA submission is compliant with regulatory requirements, reducing the risk of delays or rejection.
Communication: We will keep you informed throughout the submission process, providing updates on the status of your NDA and addressing any concerns or queries from regulatory authorities.

It should be noted that our service is only used for research, not for clinical use.

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