The Investigational New Drug (IND) application is a critical document for the approval of new drugs in the United States. Ensuring your IND is accurate and meets all regulatory requirements is essential for a successful submission.
At Asphalion, we leverage over 20 years of regulatory experience to provide comprehensive IND writing services:
- Strategic Consultancy: We offer tailored consultancy to develop product-specific IND strategies, identifying CMC requirements, and performing gap analyses of non-clinical studies.
- Expert Writing: Our team handles the complete writing of all IND sections, ensuring clarity, accuracy, and regulatory compliance.
- Submission Preparation: We manage the entire submission process, ensuring your IND is ready for regulatory review.
- Lifecycle Management: We provide ongoing support to maintain and update your IND as required throughout the drug development process.
Get in touch with Asphalion to find out how our IND writing services can support your regulatory needs and streamline your path to market: [email protected]
