Page 6 - Flipbook for Biotech Showcase 2019

CLINICAL TRIALS
Efficient and effective clinical trial and research contracting can make or break a development program. Our attorneys have on a combined basis hundreds of years of clinical trials experience in jurisdictions around the world. Sheppard Mullin can offer practical solutions to the many difficult problems posed to our clients by the trials in the U.S. and those in multiple non-U.S. jurisdictions. We also have considerable experience in contracting with and managing dispute resolution with every major clinical research organization in the U.S. We save our clients countless hours on their clinical trial work.
In addition, Sheppard Mullin has good relationships with some of the largest and most important research institutions in the world. Therefore, we are well equipped to approach them and negotiate a great deal on our clients’ behalf.
CONTRACT MANUFACTURING
We have extensive experience in negotiating with, as well as representing, contract manufacturers, suppliers, and distributors. Our attorneys assist manufacturers and suppliers in designing and implementing distribution programs, negotiating exclusive and non-exclusive manufacturing agreements on behalf of customers and suppliers, and structuring and negotiating all manner of joint ventures, development programs, and teaming arrangements. We have very specialized regulatory experience and can even perform GMP audits.
FDA REGULATORY, AUDITS
We advise manufacturers and distributors of drugs, biologics, and medical devices and other FDA regulated entities on compliance with the Federal Food Drug and Cosmetic Act, and in obtaining product approvals. We also represent these companies in FDA rulemaking proceedings and in informal enforcement proceedings brought by FDA and informal enforcement proceedings brought by the U.S. on behalf of the FDA. We conduct FDA regulatory and due diligence audits and provide regulatory due diligence with regard to life sciences transactions. We also assist companies regulated under the Prescription Drug Marketing Act, including advice on sampling, product distribution and return, re-importation and wholesaler registration requirements, and requirements for storage and handling of prescription drugs, including compliance with Drug Enforcement Administration requirements. We also advise advertising agencies, clinical investigators, research organizations, and other non-manufacturers on compliance with the Federal Food and Drug and Cosmetic Act.
LABOR AND EMPLOYMENT
Because life sciences companies operate daily under strict government regulation, the risk of a wrongful termination suit in violation of public policy is greater than with most companies. As easy as it is for an employee to raise one of these claims, it is equally as easy for management to miss the fact that the claim is coming. Because discussions regarding operating procedures, protocols and test results are so common in the life sciences workplace, managers may not realize that the discussion can create a higher risk of employment litigation.