Healthcare & Life Sciences Attorneys

areas of practice

HEALTH LAW TRANSACTIONS & BUSINESS LAW

LIFE SCIENCES / FDA CLINICAL TRIALS

HEALTH LAW TRANSACTIONS & BUSINESS LAW

We handle business law and transactions in the healthcare industry such as:

Employment & Consulting Agreements
Non-Competition Agreements
Non-Disclosure Agreements
Technology Agreements
Health Practice Business formation (S-corporations, professional corporation, partnerships)
Healthcare Business Commercial Leases

We also know that you want to practice your craft, not manage an office. Our years of experience in healthcare management and operations are available to you at healthcare consultant fee, rather than a healthcare attorney legal services fee.

HEALTHCARE REGULATORY

LIFE SCIENCES / FDA CLINICAL TRIALS

HEALTH LAW TRANSACTIONS & BUSINESS LAW

As healthcare attorneys, we monitor the changing healthcare legal and regulatory environment as well as the technological developments that drive healthcare. We have an eye for risk management and for mitigating exposure to federal and state regulatory agencies. Some legal and regulatory compliance challenges include:

Board investigations and disciplinary issues
Concierge medicine legal issues
Corporate practice of medicine
Healthcare fraud and abuse (anti-kickback, Stark and state law self-referral prohibitions)
HIPAA
Management Services Organization (MSO) issues

Rely on our experience and allow us to guide you through the healthcare regulatory labyrinth.

LIFE SCIENCES / FDA CLINICAL TRIALS

We assist pharmaceutical and medical device companies with clinical trials, both prior to approval and post-approval, and negotiate and draft contracts related to the development, manufacturing and marketing of new products.

Our services include drafting and negotiating:

Clinical trial agreements for U.S. and ex-U.S. sites
Preparing negotiation guidance for clients and CROs
Manufacturing and quality agreements
Consulting and services agreements
Review of informed consent documents
Business Associate agreements
Data Use Agreements
License Agreements
Confidentiality and Material Transfer Agreements
Review of advertising and marketing content for enforcement and litigation