Regulatory Solutions

SENSYO offers diverse high-level regulatory consulting services on virtually all industry matters subject to the jurisdiction of the Food and Drug Administration, Environmental Protection Agency, the EMEA, Japan's MHW and other U.S and EU Federal and State regulatory agencies with related responsibilities. Included in the client services offered are:

• Interpretation of rulings and policies of FDA, EPA, and other agencies, as they relate to a client's product or practices.
• Continuing advice on current regulatory and policy developments at FDA and other government agencies, including reports on the deliberations of advisory committees, the analysis of proposed regulations, key legislative proposals and Agency priorities.
• Current reports on status of products under review and approval by FDA such as OTC ingredients, new drugs, color additives, food additives and GRASP substances.
• Current reports on status of products under review by EPA such as pesticides, pre-manufacture notifications (PMNs), toxic substances and hazardous wastes.
• Assistance in direct and indirect liaison between clients and government agencies.
• Evaluation of product composition, labeling, advertising and promotion from the standpoint of compliance with applicable agency rulings and policies. This includes such factors as nutritional labeling for foods, cosmetic ingredient labeling and OTC drug monographs.
• Advice and assistance on preparation, submission and monitoring of applications for new human or animal drugs, medical devices, antibiotics, food additives, pesticides, food standards and color additives.
• Counsel on the design and implementation of strategy and programs for complying with all applicable FDA requirements.
• Advice and assistance in the preparation, submission and monitoring of applications, petitions and advisory opinions.
• SENSYO will arrange for and attend meetings with agency officials on behalf of its clients when appropriate.

Additionally, SENSYO offers a full range of Prescription and OTC Drug Consulting Services, including:

• Evaluating product composition, labeling, advertising and promotion to comply with agency rulings and policies
• Advising and assisting with preparation, submission and monitoring of applications for new human or animal drugs (NDA or NADA), antibiotics (AADA) and Drug Master Files (DMF)
• Counseling on the design and implementation of FDA compliance strategies and programs
• Interpretation of rulings and policies of FDA, EPA and other agencies as they relate to products or practices
• Providing updates and advice on current regulatory and policy developments at FDA and other government agencies including:
  • Advisory committee deliberations
  • Analysis of proposed regulations
  • Key legislative proposals and agency priorities
  • Issuing status reports of products under review and approval by FDA such as OTC ingredients, new drugs and generic drugs
  • Assistance with direct and indirect liaison between clients and government agencies
  • Arranging and attending meetings with agency officials on behalf of our clients
  • Serving as an expert witness and providing testimony on litigation involving Rx and OTC drugs

View a list of Regulatory Acronyms