Novel Approaches

In addition to our wide-ranging capabilities in aerosols, barrier pressurized packs, tubes, liquids, and semi-solids, we also support the production of medical devices — products that are used to treat medical conditions but do not contain any formally recognized pharmaceutical actives. Medical devices represent one of the more unique and novel approaches to delivering therapeutic value, aligning perfectly with our expertise.

We hold ISO 13485 certifications and possess extensive experience in supporting customers with 510(k) submissions for FDA marketing clearance. Our team is proficient in creating formulations based on predicate devices. Our portfolio includes developing a broad range of medical devices, from topical anesthetics, cryosurgery, and anti-inflammation sprays to sterile saline sprays, artificial saliva, and treatments for scars and radiation burns. These devices cater to both consumer self-care and professional care applications. If you have an idea for a medical device, we are eager to hear it — and then assist in bringing it to fruition.