Smart Legal Solutions for complex contract negotiations.
Our life science clients appreciate practical GC-level business law advice delivered on-demand: when they need it and where they need it–working either on-site at the client’s location as a dedicated resource or remotely on-demand on projects.
Legal Disciplines
Industries
Our exclusive focus is the pharmaceutical, biotechnology and medical device industries.
Pharmaceutical
We focus on Pharmaceutical law that regulates the research, development, manufacturing, marketing, and distribution of drugs, ensuring safety, efficacy, and quality.
Biotechnology
We work in Biotechnology law, including specialized fields governing the research, development, and commercialization of biotech products, heavily focusing on intellectual property (patents), FDA regulatory compliance, and business transactions.
Medical device
We help companies navigate compliance and liability issues. Manufacturers must follow Quality System Regulations (QSR) for design and manufacturing. Non-compliance can lead to recalls, warning letters, or seizures
How We Work
Practice Areas
01
Manufacturing
We handle Manufacturing law that covers the regulations governing industrial production, focusing on product liability, safety standards, and compliance.
02
Clinical Trials
We specialize in Clinical trial legislation which focuses on protecting participant rights, ensuring data integrity, and enhancing trial transparency.
03
Contract Research
We handle contract research law that governs agreements where a sponsor delegates research responsibilities to a third-party Contract Research Organization (CRO) or institution.
EXPERTISE
Transactional Experience
Voyager Therapeutics, Inc.
While at Voyager Therapeutics, Inc. (VYGR), External GC Law Group provided legal advice on a variety of day-to-day legal and business matters as well as business development transactions that raised in excess of $400 million in non-dilutive financing (e.g., AbbVie, Neurocrine Biosciences, Novartis and Pfizer). While at VYGR, he negotiated key agreements with contract manufacturing organizations (CMOs) and contract research organizations (CROs).
AMAG Pharmaceuticals, Inc.
While at AMAG Pharmaceuticals, Inc., External GC Law Group provided legal advice on a variety of day-to-day legal and business matters as well as strategic transactions, including AMAG’s acquisition of Lumara Health and its product MAKENA ®, a variety of manufacturing and supply agreements, clinical trials in a variety of countries, and financings raising over $1.2 billion in equity and debt.
Hale and Dorr, LLP
While at Hale and Dorr LLP, External GC Law Group advised Critical Therapeutics, Inc. (CRTX) in its $56 million venture financing in 2003 and its $42 million initial public offering in 2004. As General Counsel at CRTX, he advised on in its $54 million PIPE, $20 million registered direct financing, its two co-promotion agreements for marketed drugs, and a variety of manufacturing, distribution, licensing and vendor agreements.