Consolidating the scientific and regulatory information required to support a submission for marketing approval is a critical step for any drug development program. Yet many teams struggle with setting and adhering to a timeline for planning, drafting, reviewing, and editing the regulatory documents needed for the submission dossier.
Our regulatory experts compiled some of the most common submission planning mistakes and tips for addressing them, to ensure you have a successful submission.
Inside this whitepaper:
- Understand the phases of a submission program
- Takeaway tips for establishing a robust and detailed submission plan
- Takeaway best practices to deliver an on-time submission
Having a strong plan that is well communicated enables your team to have a smooth submission process that both minimizes project-related stress and optimizes your drug’s probability of regulatory success. Complete the form to get started now!
