At Protheragen MedAI, we provide complete regulatory support during drug development to ensure that your product is in compliance and successfully manages the regulatory approval process. Our team of specialists provides customised solutions for various regulatory filings such as Investigational New Drug (IND), New Drug Applications (NDA), Drug Master Files (DMF) and many more.

Investigational New Drug (IND) Applications

Pre-IND Consultation

• Provide consultation on drug registration regulation
• Provide project evaluation and risk analysis
• Design registration application strategy
• Estimate project costs, plan project timelines, and ensure compliance

IND Submission

• Pre-IND meeting preparation
• CTD document review, translation, and preparation
• IND document preparation and submission
• Communication with regulatory agencies
• Site inspection preparation
• Management and tracking of the entire application process

Ongoing IND Support

Management of IND amendments, responses to regulatory queries, and reporting of adverse events during clinical trials.

New Drug Applications (NDA)

• Analyze the feasibility of NDA registration of the drug in the U.S. based on U.S. regulatory requirements
• Gap analysis of registration dossiers and pre-review of drug information
• Pre-NDA/BLA meeting assistance
• eCTD publishing and electronic submission
• Follow-up of the official review process of drug registration
• Providing responses and supplementary materials to the FDA's follow-up inquiries and requests for further information
• Pre-review of cGMP compliance
• Project planning and management
• FDA communication
• Post-approval support

Abbreviated New Drug Applications (ANDA)

• Analysis of the feasibility of ANDA registration of the product in the US based on US regulatory requirements
• Regulatory consulting during the product development and manufacturing stages to guide clients in complying with specific requirements, such as product development through QbD methodology and GDUFA program implementation.
• ANDA file checklist sharing
• Gap analysis and regulatory assessment of generated source data
• Pre-submission management activities such as facility identification, DUNS/FEI/ANDA application number requests, etc.
• Preparation, translation, review, and submission of ANDA registration materials in CTD format according to current FDA and Refuse to Receive (RTR) requirements
• Full tracking of the official drug registration review process and communication with the FDA for the ANDA approval
• Assisting clients in preparing additional/missing documents for RTR/GDUFA compliance
• Regulatory strategy and response preparation for inquiries, such as IRs, DRLs, or CRLs during the ANDA approval process
• cGMP audits and guidance to clients to complete corrections on time

Drug Master Files (DMF)

Preliminary Preparation

• DMF basic training, including the introduction of the U.S. DMF, management systems, etc.
• Provide DMF declaration outline according to FDA's regulatory requirements
• Regulatory submission strategies for different DMF types
• Gap analysis of registration data and pre-review with drug information

DMF Preparation and Submission

• Analytical testing, including elemental analysis, validation, stability, etc.
• Review, translation, preparation, and submission of registration documents in CTD format
• U.S. agent service for DMF filing
• Establish ESG submission channel

DMF Review

• Technical liaison with FDA in the review process and answering questions
• Regulatory strategy, preparation, and submission of amendments and annual reports for registered drug master files

DMF Maintenance

• Activate or deactivate DMF
• Assist the GMP department with on-site inspections if needed

Our team of regulatory affairs experts will support you from concept to execution in all phases of drug development so that your product is prepared to pass regulations and on time. With our support, you can breeze through the regulatory process in no time, and concentrate on bringing your novel treatments to market. To learn more about how our regulatory support services can help your drug development initiative, please contact us.