Product Approvals and Dispute Resolution

Representative experience

Helped persuade the FDA to accept our client’s proposed development plan after the client reached an impasse with the division on data requirements for a new dosage form.

Persuaded an FDA review division to remove a "clinical hold" placed on the study of a pharmaceutical company client’s breakthrough auto-injector for use with a well-known topical analgesic drug.

Successfully appealed, through formal FDA dispute resolution mechanisms, the denial of a proposed trade name for a biotechnology company client’s breakthrough biotechnology product.

Helped a biotechnology client ascertain the U.S., state, EU, and EU member state requirements for replacing the syringe for an injectable medicinal product.

Accompanied a client looking to get a product back onto the Brazilian market to the Agência Nacional de Vigilância Sanitária (ANVISA), Brazil’s FDA counterpart.

Advising clients in a successful challenge of a refusal by a notified body to renew CE Certificates of Conformity for medical devices.

Advising a client in an investigation of its distribution in the EU of incorrected labelled third party medical devices.

Advising clients securing agreements with the National Health Service (NHS) to fund their innovative and lifesaving medicines.

Assisting clients in the matters before the Polish Office for Registration of Medicinal Products, concerning the permissibility to sell medical devices after their notified body lost its notification.