LIFE SCIENCES: DESCRIPTION

The life sciences industry is vast, including the fields of Food & Drugs, Medical Devices, Agriculture, and Pesticides. These fields are closely linked to some of our other specialty areas, such as Biotechnology, Pharmaceuticals, and environmental law.

McKenna Long & Aldridge assists life science companies across a wide front, including regulatory issues, intellectual property and corporate needs, and European law.

Food and Drugs

Attorneys in the Life Sciences fields represent manufacturers, processors and distributors of foods and drugs, medical devices, trade associations and research institutions. We have experience in all areas of food and drug law and represent a broad range of backgrounds and experience, including technical backgrounds in pharmacy, physics, and pharmacology. Our practitioners also bring to the practice a wide mix of experience in government, trade and legal associations, and in corporate legal, quality, and regulatory responsibilities.

Medical Devices

MLA helps trade associations, manufacturers, and distributors of medical devices on issues ranging from regulatory strategy development and premarket clearance procedures to efforts to lessen product liability exposure of marketed devices. Other services in the medical devices field include:

  • developing regulatory strategy documents and corporate policy drafts
  • representing clients facing FDA enforcement litigation and in formal and informal administrative hearings
  • aiding device clients in complying with defect reporting requirements for medical devices
  • counseling clients on recall planning and execution
  • advising clients on good manufacturing practice (GMP) systems, issues and corrective actions

Pesticides

MLA has been the leading authority in the field of pesticide regulation since it began. We have represented numerous individual and trade association clients in some of the most important pesticide cases and regulatory developments of the last 30 years. Our publication, the Pesticide Regulation Handbook, is considered the source for FIFRA information throughout the legal community. Our lawyers counsel pesticide clients on a wide range of concerns, including:

  • Cancellation and suspension
  • Groundwater regulation
  • Tolerance establishment and cancer risk assessment
  • Data compensation
  • Compliance audits
  • European pesticide registration

Agriculture

MLA is experienced in international trade issues that affect the fertilizer, pesticide, livestock and commodity industries. We assist clients with the international registration and harmonization of crop protection chemicals and biotechnology products; food labeling requirements; tariff and duty suspension; and phytosanitary and quarantine regulations.

We also counsel on chemical and pesticide regulation, including federal, state and international laws affecting the manufacture, marketing and use of agricultural, antimicrobial and non-agricultural pesticides.

European Law

MLA provides a broad range of services in the field of European environmental law and product regulation, including product liability issues. Our expertise in these areas is based on the extensive experience of the attorneys in our Brussels and several U.S. offices, together with a close working relationship with our scientific consulting affiliate, Technology Sciences Group Inc. (TSG).

This field of practice centers on the regulatory and administrative controls governing the production, sale, classification, packaging, and labeling of pesticides, chemicals, biocides, food, novel food, cosmetics, medicines, and medical devices under both EU and Member State law. In addition to guiding clients through the maze of EU environmental regulations, we often lobby EU institutions on our clients' behalf before legislation is adopted. In this work, we benefit from a close working relationship with EU and Member State officials.