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.
Bioetechnology 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.
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.
On the FDA side, we handle:
- 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
Our life sciences clients include companies at all stages of development, including:
- 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
And we handle many other types of life sciences ventures.
FAQ
Great! Let us know and we’ll do a conflicts check and then send you an engagement letter. Typically we want to know if we are going to represent you as an individual, or your entity (corporation or LLC); we’ll also want to know your website and some basic contact information.
Review our legal services to see some of the areas we like to work in; check our testimonials, client roster, and experience; read some of our blog posts; check out our Linked In community; or just call or email us to explore. Put simply, we represent health and wellness products, technologies, practices and ventures that accelerate health and healing.
We are very comfortable working with clients via phone and email. You can sign, scan and email the engagement letter, and submit the advance by check or online.
The answer depends on the complexity of the project. Each client’s situation is different. We want every client to receive the best possible advice, and so we want to be in a position to devote as much time as is required to do that. Look to our testimonials, client roster, and experience. We work with our clients effectively and efficiently and build long-term relationships based on mutual trust. We bill hourly and do not offer project or flat fees. Lawyering is an art, not a science – we’re intuitive as well as skilled lawyers.
Yes, like most law firms, we require an advance against fees and costs. Our typical advance ranges from $3,500 – $10,000. We offer our expertise and savvy and work hand-in-hand with you toward your goals. Occasionally, we will offer you a one-hour consult as a way to jump-start our work together, and give you an overview of critical issues, with guidance on the critical business cross-roads you’re facing. We do not take equity or deferred compensation.
Our Firm doesn’t quite “quotes” or answer “how much does it cost.” Through long experience, we’ve found that the answer is pretty much meaningless. Some lawyers and law firms give quotes, but if you read the accompanying disclaimer, you’ll see that the disclaimer basically says that you can’t depend on the quote for anything. In our long experience, “how much it costs” depends on a lot of variables, including:
- What the client is asking for
- What the client really needs
- What the client doesn’t know they don’t know
- What we discover as we dive into the legal research and analysis
- How complicated the problem really turns out to be
- How much client will want to do on their own
- Whether we can find some elegantly simple solutions to sub-parts of the puzzle
- What decisions we make together, and separately, as we explore the puzzle and put solutions and strategies together
In many cases, we might think a project is very complex but then as dig in, we can make executive decisions and recommendations that save the client dozens of hours of lawyer time and tens of thousands of dollars. This happens a lot with our clients. In other cases, the client might think the problem is simple but as we start to review it, the puzzle is much larger; sometimes the client throws in extra facts and complications at the last minute, and that will increase the expense and work; sometimes we’ll give the client “homework” so they can DIY a piece, taking it outside the need for lawyer time.
One thing we do is get our clients frequently on the phone. We find that the Legal Strategy Session often cuts through the fog. Where we need to do a chunk of written legal work, we’ll do so and let you know that’s what we think is needed. Where we can be more efficient with a call, we’ll tell you that as well.
Many clients come us after having wasted tens of thousands of dollars with other lawyers. Read our testimonials. We’re here to provide a lot more value than the retainer—our business model and Firm policy is to provide at least 3-5 times the value back to you. That’s our model and we’re sticking to it. We’re not trying to sell you on a “cheap retainer” or promise of discounts. We’re here to solve a big hairy problem and get you where you need to go, as efficiently and productively as we can.
Typically, assessing feasibility involves legal and strategic advice, which we provide in the 45-minute consult, in a way that is appropriate to the time we have together there.
The only way to know is to jump into the process. If you want to know more about us and how we work, browse our testimonials, look at our client rolodex, or review our experience on our website.
Work with us and find out how efficient and engaged we are with your business. We like to work with clients for life. It is a deep and trusting relationship.
Michael’s bio is online here. He has written books on healthcare law and policy, taught healthcarelaw as a faculty member at Harvard Medical School, garnered NIH and other medical research grants, and published over 100 articles in legal and medical journals. Michael speaks all over the world on healthcare topics.
