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:
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.
Please contact us via email or at +1-201-894-8200 to discuss your needs or to get further information about how we can support your upcoming orphan drug meetings and preparation.