Biotechnology Legal & Compliance
Guidance
Guidance
Biotechnology and life sciences companies can face a host of regulatory requirements, from the FDA, FTC, and other three-letter agencies, and require a realistic appraisal of the regulatory barriers and what they can do to overcome them.
Agreements for Biotechnology & Life Sciences Clients
Our biotechnology and life sciences lawyers understand FDA, FTC, and relevant state laws that apply to your business. We provide regulatory compliance advice and corporate legal services, and can help you with:
- Acquisition Agreements
- Clinical Research Agreements
- Collaboration Agreements
- Dietary Supplement Structure/Function Claims
- Distribution and Manufacturing Agreements
- Drafting FDA-Compliant Product Labels
- Financing Agreements
- Intellectual Property and Technology Transfer
- Joint Venture Agreements
- Legal Review of Marketing Materials for FDA and FTC Compliance
- Licensing Agreements
- Manufacturing Agreements
- Medical Device 510(k) Review
- Private Label Agreements
- Regulatory Advice on Food Supplements
- Sales Representative Agreements
In the biotech and life sciences industry, corporate agreements are not the run-of-the-mill, standard templates that other businesses sometimes try to grab off the Internet.
Rather, the deals require customized care and attention, including:
- Protecting the intellectual property (IP) of the life sciences or biotechnology venture;
- Managing key business points such as pricing, payment terms, and setting other legal boundaries;
- Capturing the value of the product or service and then protecting the company through strong indemnification, confidentiality, and other essential terms.
At every phase of company development, our biotechnology and life sciences lawyers work with our clients to maximize company value.
Our life sciences and biotechnology lawyers cross-collaborate to ensure coverage of regulatory issues as well as corporate law issues, IP protection, real estate issues, corporate governance, and nitty-gritty business deal points of agreements the life sciences company may make with ventures, strategic partners and affiliates, and others.
Our life sciences and biotechnology lawyers cross-collaborate to ensure coverage of regulatory issues as well as corporate law issues, IP protection, real estate issues, corporate governance, and nitty-gritty business deal points of agreements the life sciences company may make with ventures, strategic partners and affiliates, and others.
Why Biotech Law Matters
The biotechnology and life sciences industry operates at the intersection of science, innovation, and strict regulatory compliance. From biotech companies and pharmaceutical manufacturers to medical device makers and clinical-stage biopharmaceutical companies, every breakthrough must meet complex FDA regulatory and intellectual property requirements.
In this fast-evolving sector, even small missteps can lead to serious risks, including intellectual property theft, FDA compliance violations, or costly contract disputes. Navigating these challenges requires not only legal skill but also a profound understanding of the life sciences sector, the Prescription Drug Marketing Act, drug pricing laws, and emerging regulatory frameworks impacting biotechnology innovators.
That’s where experienced biotech lawyers make a difference. At Cohen Healthcare Law Group, our attorneys combine extensive experience in biotech law, FDA law, and intellectual property protection to help life sciences companies safeguard their innovations, manage risk, and achieve commercial success. We work closely with emerging and established companies, healthcare providers, and research institutes to create strategies that align legal compliance with business growth. Our goal is to help you focus on advancing science while we protect your discoveries.
Industries We Serve
At Cohen Healthcare Law Group, our biotech lawyers and life sciences attorneys counsel a broad range of clients across the biotechnology and healthcare sectors. Whether you’re launching a biotech startup or managing compliance for a global pharmaceutical company, our team provides strategic legal support tailored to your industry. These industries include:
- Biotech Startups: We advise emerging biotech companies and clinical-stage biotechnology companies on everything from intellectual property protection and FDA regulatory compliance to venture capital, strategic alliances, and technology transactions. Our goal is to help innovators navigate complex biotech law while setting a strong foundation for growth.
- Pharmaceutical Companies: Our attorneys represent pharmaceutical companies through every stage of product development and commercialization. We provide counsel on drug discovery, clinical trials, marketing compliance, and issues under the Prescription Drug Marketing Act, ensuring compliance and risk management throughout the process.
- Research Institutions and Universities: We work with research institutes and universities developing groundbreaking biotechnology. Our team assists with intellectual property strategy, patent prosecution, and technology licenses, helping clients turn research into viable, protected innovations.
- Medical Device Manufacturers: From product development to post-market compliance, we support medical device manufacturers navigating FDA regulations, patent disputes, and technology partnerships. Our FDA lawyers have profound knowledge of the Food and Drug Administration’s complex regulatory framework and provide strategic legal advice to help clients bring devices to market efficiently and safely.
- Genomics and Personalized Medicine Companies: As the life sciences industry evolves toward precision health, we guide genomics and personalized medicine companies through legal issues surrounding data privacy, intellectual property, and regulatory compliance. We help ensure that innovation aligns with ethical and legal standards while positioning clients for long-term success.
Why Choose Our Biotech Patent Attorneys?
With decades of combined experience in biotech law, FDA regulations, and intellectual property protection, we offer the depth of knowledge necessary to navigate one of the most highly regulated sectors in the world. Here’s why you should work with us:
- Experienced in Biotechnology Law and Life Sciences: Our attorneys have extensive experience advising biotechnology companies, pharmaceutical companies, and medical device manufacturers on complex regulatory requirements, patent litigation, and technology transactions. We understand the nuances of biotech law, from clinical trials to capital markets practices, ensuring that your company’s innovations remain secure.
- Proven Track Record with Patent Filings and Regulatory Compliance: Our biotech lawyers handle every aspect of patent prosecution, patent disputes, and regulatory compliance. We’ve represented emerging companies, clinical-stage biopharmaceutical companies, and established life sciences firms before major regulatory bodies, including the Food and Drug Administration.
- Deep Understanding of Biotech Industry Trends and Challenges: From drug pricing and biologics price competition to evolving FDA regulatory and intellectual property frameworks, we stay ahead of industry developments to deliver informed, strategic advice. Our life sciences attorneys understand how these trends affect biotech clients, private equity firms, and venture capital investors in the life sciences sector.
- Personalized Strategies for Startups, Mid-Size, and Large Companies: We recognize that each biotech company faces unique challenges. That’s why our biotech patent attorneys develop tailored legal strategies that align with your business goals.
Bietechnology and Regulatory Issues
Our biotechnology and life sciences lawyers are familiar with the regulatory framework that underpins the transactions. We can thus draft and negotiate agreements with an understanding of the legal constraints and opportunities.
Regulatory Counseling & Corporate Legal Advice
Specific examples of our regulatory counseling and corporate legal advice include:
- Advice to medical device companies concerning FDA regulatory requirements to bring their product to market, including substantial equivalence review.
- Counsel to a client with respect to an FDA investigation and seizure of imported products, and FDA-766 application to re-label.
- Counseling providers on billing, reimbursement and claims issues; anti-kickback, and physician self-referral (Stark) regulations; as well as Medicare issues.
- Drafting licensing and technology transfer agreements for a medical device start-up.
- Evaluation of fraud and abuse issues and advice concerning business structure for a company involved in preventative, diagnostic screenings, and imaging.
- Legal guidance to a cosmetics start-up concerning marketing claims and over-the-counter (OTC) drug regulations.
- Review of marketing practices for a telemedicine company promoting off-label drug use.
FDA & Product Compliance Services
- Administrative support software
- Adulteration and misbranding
- Clinical decision-making (CDS) software
- Combination products
- Cosmetics labeling
- CURES Act issues
- Direct-to-consumer Genetic Health Risk (GHR) tests
- Dietary supplement labeling
- FDA Warning Letters and FDA Form 483s
- General wellness products
- Genetic variant detection and health risk assessment systems
- Health claims
- In vitro diagnostics
- Medical image communications devices
- Medical device data systems (MDDS)
- Medical image storage devices
- Mobile medical apps
- Personal Use Importation
- Pharmacy compounding issues
- Regulatory classification of medical devices
- Structure/function claims
- Other FDA issues
Life Sciences Industry Clients
- Companies pioneering genomics, DNA-based diagnostics, and therapeutics
- Cosmetics, dietary supplements, and nutraceutical companies
- Diagnostics companies
- eHealth, mHealth, and telemedicine companies
- Medical device companies
- Mobile medical app manufacturers
- Personalized healthcare (P4) companies
- R&D companies
- Stem cell and regenerative medicine enterprises
- Wearable health technology companies
FAQ
At Cohen Healthcare Law Group, our biotech lawyers and FDA attorneys frequently receive questions from biotechnology companies, pharmaceutical firms, and medical device manufacturers about how to protect their innovations, comply with FDA regulations, and navigate evolving intellectual property laws. Below are answers to some of the common questions we get:
A biotech lawyer advises biotechnology companies, pharmaceutical firms, and medical device manufacturers on complex legal issues such as intellectual property, FDA regulatory compliance, and clinical trials. They help clients navigate the intersection of science, law, and business to ensure innovation and compliance.
Yes, biotech patent attorneys assist with patent filings, patent prosecution, and patent disputes, ensuring that life sciences companies protect their discoveries and maintain ownership of valuable intellectual property.
FDA lawyers guide biotech clients through the regulatory processes of the Food and Drug Administration, helping ensure that products meet FDA regulations before and after approval. They also advise on labeling, marketing compliance, and post-market surveillance requirements.
The cost of hiring a biotech lawyer depends on factors like case complexity, project scope, and attorney experience. At Cohen Healthcare Law Group, we offer transparent, customized pricing to meet the needs of emerging companies and established life sciences firms alike.
An FDA attorney is a legal professional specializing in the laws and regulations enforced by the Food and Drug Administration. They advise biotechnology, pharmaceutical, and medical device companies on compliance, approvals, and enforcement matters.
Yes, our biotech lawyers counsel clients on global regulatory compliance, including international clinical trials, foreign corrupt practices, and cross-border technology transactions, ensuring smooth operations across markets.
Biotech companies often face challenges related to intellectual property protection, FDA compliance, patent disputes, and contract negotiations. They also navigate issues in drug pricing, venture capital, and strategic alliances that require experienced legal guidance.
