ECG has experience working with companies bringing orphan drugs and biologic products to the FDA, both for orphan drug designation and regulatory approval. We know and approach strategically the statutes and requirements that govern the processes through which orphan drug status is achieved and approval granted.
In particular, ECG can assist your company in:
- Analyzing your audience(s)
- Designing a clear, compelling, and integrated communication plan
- Reworking messages to address requirements specific to orphan drugs and biologics
- Identifying and resolving issues that may exist or appear to exist
- Making your case with a lowered statistical burden
- Using unique rhetorical and visualization techniques developed specifically for small data
We understand the importance to the patient population and thus to your company of orphan drugs and biologic products. ECG can assist you in getting these drugs into the hands of physicians and their patients for the benefits they offer and deliver.
