Desai & Diwanji, being a full-service firm, has the expertise to guide its clients through the Pharmaceuticals and Life Sciences legal landscape. Our team consisting of experienced and knowledgeable professionals has a deep-rooted understanding of the regulatory and policy drivers of the market and have experience across the vast expanse of the healthcare sector including pharma manufacturing, drugs and cosmetics, pharma and e-commerce, nutraceutical products, medical devices.
Since the pharma and life-sciences sector is diverse, the expertise of our litigation, intellectual property, eDiscovery, corporate, finance, and employee benefits attorneys, is optimally utilized in servicing this sector and all the attorneys stay abreast of the ever-changing regulations and legal developments in this sector so that we may assist our clients with day-to-day compliance, provide to-notch coverage and also devise long-term strategies. We provide legal solutions and results that support our client’s overall business objectives.
Our Corporate attorneys represent pharmaceutical and life sciences clients in mergers, acquisitions, and divestitures, as well as in drafting and reviewing licensing and wholesaler agreements, distribution agreements, product sales, manufacturing agreements, group purchasing agreements, supply agreements, and distribution agreements for both generic and branded manufacturers, distributors, and wholesalers. We also assist with start-up financing, private placements, and public offerings.
Our life science clients look to us for help in evaluating, developing, and implementing comprehensive, effective fraud and abuse compliance programs in order to minimize the risks of financial loss and criminal prosecution resulting from regulatory and qui tam enforcement actions. Additionally, certain attorneys within our Corporate Practice are focused on the life sciences and high-tech industries, providing legal services support to start-ups, emerging companies, and technology transfer offices.
The firm’s pharmaceuticals and life sciences team deliver insightful, practical guidance and sophisticated representation to a full spectrum of companies, on every type of transaction or dispute a company may face. The team assists and counsel’s clients (such as public and privately held domestic and international companies, financial institutions etc.) on ways to integrate Pharmaceuticals and Life Sciences factors in their business operations and transactions. We have an Effective Team of corporate law attorneys to ensure statutory compliance under the Various Acts and the Rules made thereunder. We have also advised on:
- formulating trade secret protection policies and facilitating the infrastructure for privacy and data protection
- training programs for institutional ethics committees and key stakeholders around clinical trials, practice, and procedure
- preparation of privacy policy, terms and conditions, and informed consent agreements for health-it applications
- crisis management in cases of liability claims- determination of liability and fault, defending claims before the courts of law and addressing issues of compensation and insurance
- advise branded and generic pharmaceutical companies in areas involving rebates, discounts and pricing matters
- develop fraud and abuse and sales and marketing compliance training programs and compliance plans
- reviewing and drafting corporate codes of compliance
- provide analysis of regulatory concerns involved with product and company acquisitions
- advise pharmaceutical and medical device companies regarding pricing, sales and marketing initiatives
- advise pharmaceutical and medical device clients with respect to licensing agreements, manufacturing and supply contracts, fraud and abuse compliance, group purchasing agreements, medical director agreements, and compliance with marketing standards
- handling complex transactional issues and giving general client advice regarding a wide range of corporate and commercial concerns within the pharmaceutical industry
Members of our team interact on a regular basis with various regulatory authorities and are frequently consulted by them to advise and assist on matters of policy and governance. These relationships offer our team members a unique insight into the views and objectives of such and regulatory authorities, which enhances the holistic advice and solutions that we offer to our clients.