Regulatory / Law Services

 

Our legal partners have comprehensive experience in the food, drug and cosmetic law area. We provide clients information on the increasingly complex responsibilities and requirements of food, drug and cosmetic manufacturers, advertisers, distributors and retailers.

One method of employing ST&T's resources that has certain advantage for law firms and/or industries, is utilizing an ST&T consultant to help with case screening, review organization of records and data, and even trial preparation, specially with respect to the past state-of-the-art, medical standard-of-care, regulatory, labeling, or notice or risk assessment questions. In addition, consultants are available to give expert testimony if the situation requires.

ST&T Client Support Services include:

  •  Developing compliance strategies and responses to FDA Warning Letters and State embargoes.
  •  Counseling clients on the legal aspects of developing food, dietary supplements, drug and cosmetic products.
  •  Guiding firms through FDA inspections and informal enforcement efforts.
  •  Compiling New Drug Applications.
  •  Handling food additive status matters and petitions.
  • Monitoring developments in the food and drug law field through services and publications offered by The Food and Drug Law Institute and service on the Food and Drug Law Committees of the Chicago and American Bar Associations.

ST&T Litigation Support Services:

Our experiences with litigation cover a vast range of subjects. Robert Armstrong has experience with private lawsuits as well as defending clients in cases prosecuted by a variety of state and Federal regulatory agencies including the Federal Trade Commission, the U.S. Food and Drug Administration, the United States Postal Service and State Attorneys General.

Experiences include preliminary injunctions, pre-trial discovery, summary judgment and other dispositive motions, trial work, administrative hearings, post-trial briefs and appellate practice.

ST&T Legal Consulting Team Headed by Robert Armstrong, Esq

Corporate and Commercial Support Services:
  •  Negotiating and drafting manufacturing, sales, distribution and expert consultation agreements.
  •  Enforcing rights under business contracts.
  •  Handling the incorporation and expansion of various corporate entities.
  •  Acting as general counsel to national and international businesses as well as professional trade associations.
  •  Servicing a wide range of business' legal needs and requirements.
Advertising Contractual Support Services:
  •  Advising clients on legal requirements of advertising substantiation.
  •  Litigating under the Lanham Act, a Federal law allowing for injunctions and damages resulting from deceptive or unfair advertising by competing firms.
  •  Defending lawsuits involving State consumer protection laws allowing private lawsuits challenging advertising.
  •  Advising clients on dealing with varied and often inconsistent interpretations of Consumer Protection Statutes enforced by State Attorneys General.
International Trade and Customs Support Services:
  •  Handling problems associated with importation and clearance of shipments through Customs.
  •  Filing petitions in response to claims for liquidated damages by the United States Customs Service.
  •  Advising importers and exporters of food, drugs, cosmetics and medical devices.
  •  Negotiating and monitoring purchase and supply contracts with international manufacturers, vendors and purchasers.
  •  Monitoring the progress of the reduction of trade barriers within the European Community.
Unfair Trade Practices and Business Tort Support Services:
  •  Misappropriation of trade names.
  •  False and misleading advertising.
  •  Interference with contractual relations.
  •  Protection of trade secrets and formulas.