A biocommercialization strategy should anticipate navigating the complex web of post-regulatory, reimbursement, antitrust, and enforcement issues that arise once a product is on the market. Such issues arise with pharmaceutical and biologics manufacturers, including product quality and FDA inspection issues, under regulations such as current Good Manufacturing Practice (cGMP) requirements that provide minimum requirements for the manufacturing facilities and the manufacture, processing, packing, and storage of a drug. These legal issues may further involve the safety, efficacy, identity, quality and purity of the marketed pharmaceutical or biological material. Attorneys, scientists and consultants also offer guidance for companies involved in pharmaceutical and biologics marketing.
Our clients often consider product labeling, physician interaction guidelines, creative pricing practices (including providing rebates, discounts and other promotions), and other industry guidelines in their marketing strategies. Reimbursement issues may also arise under Medicare, Medicaid, and private payor strategies. In addition, adverse event reporting for regulated pharmaceuticals and biologics involves complex statutory and regulatory regimes. A comprehensive marketing strategy also involves intellectual property protection. By analyzing and predicting the form a client's technology will take in the market, an intellectual property strategy can be developed that will enhance your position in the market by protecting what is predicted to be reimbursable, manufactured on a large scale, safe, and effective.