NDA Submission Support

Our Services

Our specialized NDA submission support service is designed to guide pharmaceutical companies through every step of the process, including:

Comprehensive Planning

We start with a detailed planning phase, which includes:

• Regulatory Strategy Development: Crafting a regulatory strategy that aligns with your drug's development plan and the requirements of regulatory agencies.
• Gap Analysis: Analyzing existing data to identify any gaps that need to be addressed before submission.
• Timeline Management: Creating a detailed timeline to keep your project on track.

Document Preparation

Our team of experts helps prepare, compile and review all necessary documents, ensuring they meet the stringent requirements. Our services include:

• Scientific Writing: Producing clear, concise, and scientifically robust documents, including preclinical and clinical study reports, pharmacokinetic data, statistical analyses, manufacturing information, etc.
• Data Analysis and Interpretation: Ensuring that all data is thoroughly analyzed and interpreted to support the drug's safety and efficacy.
• Adherence to Guidelines: Ensuring all documents comply with regulatory agencies guidelines and requirements.

Pre-submission Meetings with Regulatory Agencies

We facilitate and support pre-submission meetings with regulatory agencies such as the FDA and EMA (European Medicines Agency). Our experts help in drafting questions, preparing presentation materials, briefing package preparation, and meeting representation discuss scientific issues with the NDA filing.

Regulatory Submissions

We facilitate the submission process by:

• Compilation and Publishing: Using advanced eCTD software to compile and publish your NDA in electronic format.
• Submission Management: Managing the submission process, including communication with the regulatory agencies.
• Post-Submission Support: Providing assistance with any follow-up questions or additional information requests from the regulatory agencies.

NDA Post-Approval Lifecycle Management

Our services extend to post-approval lifecycle management including supplements, changes being effected (CBE-30), changes being effected (CBE), and annual reports.