Biotechnology and Pharmaceutical Law

American Biotechnology and Pharmaceutical Law Lawyers

New York – Princeton – Philadelphia Biotech Law Attorneys

The Bayne Law Group is dedicated to providing a full spectrum of legal services to businesses in highly regulated industries, including the biotechnology industry and pharmaceutical industry. We represent local and national corporations, as well as international corporations doing business in the U.S.

Contact us regarding your legal needs, including:

  • Regulatory compliance, including FTC/FDA
  • Collaboration arrangements for product development and commercialization
  • Clinical trials
  • Coordinating and counseling on New drug applications (NDA) and abbreviated new drug applications (ANDA)
  • Supply contracts, from API to finished packaged product
  • Product licensing, acquisition and divestiture
  • Co-marketing and co-promotion agreements
  • Product lifecycle management
  • Royalty stream monetization
  • Government contracting and subcontracting
  • Compliance counseling as well as managing and defending audits by regulatory agencies including current good manufacturing practice (cGMP)
  • Intellectual property, including trademark applications and prosecution and defense of IP claims
  • Product liability litigation defense of frivolous claims
  • Management incentive plans and third party financing transactions
  • Assistance for international and domestic industry professionals and businesses

The government is highly involved in the biotechnology / medical device industry and pharmaceutical industry to ensure the safety of consumers. Any business working in these industries must ensure that they are compliant. We can offer tremendous guidance to help your business prosper.

Whether you need assistance with new drug applications, IP concerns, audits or other industry concerns, you can rely on The Bayne Law Group for the vital support you need.

US Food and Drug Administration / Office of International Programs Compliance Counsel

The Bayne Law Group LLC assists global pharmaceutical and medical device manufacturers with FDA Office of International Programs (OIP) compliance. The firm’s international on-site services include compliance counseling and legal support for extra-territorial, non US-based FDA compliance including:

  • OIP Firm Verifications
  • OIP Routine Inspections and/or Audits
  • OIP High Priority inspections and auditing. High priority inspections include assistance for private industry involved in public health emergencies such as an outbreak, a user-fee driven issue, or issues pending a critical patent expiry, or an inspection spurred by a cause or special request by the private or public sector
  • General private legal counsel for international drug manufacturing or distribution companies engaging with the Office of International Programs in the United States and globally

From our firm’s European Service Centre in Ireland, we deploy knowledgeable staff within Europe efficiently and effectively to assist international pharmaceutical and biotechnology companies with competent and knowledgable legal support to assist with drug manufacturing facilities engaged in deliveries within the United States markets. We are also poised from a number of locations to provide legal representation globally to assist drug and biotechnology companies with all FDA compliance requirements.

Business Counsel for the Global Marketplace ®

Our clients come to us from countries throughout the world, including the United States, New Zealand, India, Canada, Australia, China, Europe, the Middle East and South America. If you need help thriving in the biotechnology or pharmaceutical industry, we encourage you to take advantage of our deep industry knowledge, vigorous advocacy and superior client service.

The Bayne Law Group headquarters is in centrally located Princeton, New Jersey. We have regional offices in New York and Philadelphia. To speak with an American pharmaceutical law lawyer or biotechnology law attorney, call 609-665-3200 or contact us toll free at 888-312-0442. You may also reach us online.