FDA Regulatory Services
Our Director of Regulatory Services, Richard Pecora, is a former FDA agent with over 30 years of experience assisting both domestic and foreign manufacturers and import/exporters with a wide variety of regulatory and compliance matters. We provide personal and customized technical and regulatory support during critical situations and will expertly represent you in dealing with the FDA and/or USDA with problematic issues relating to the regulation of cosmetics, organic/natural products and ingredients, pharmaceuticals, foods and medical devices. Special areas of focus include drug and device registration, OTC drug labeling, good manufacturing practices (cGMP’s), removal of firms or products from FDA detention without physical examination (the automatic detention list), proposals for reconditioning detained goods (FD766), insurance claims, supplemental approval issues, and domestic and import compliance disputes.
Bio-Control will expertly represent you in dealing with the FDA and/or USDA with problematic issues relating to the regulation of cosmetics
Regulatory Services
Regulatory/Compliance Problem Resolution
Representation before FDA and USDA
Drug/Device Firm Registration & Product Listing Assistance
Import/Export Problems and Issues
Removal of Firms/Products from Import Alerts
Emerging Product Development Regulatory Restrictions
Food/Cosmetic and Dietary Supplement Labeling Issues
Drug/OTC Classification/Labeling/Claims
HAACCP and Preventative Control Plan Creation
Cargo Inspection for Marine/Transportation Claims
Bioterrorism Regulation Advisory
Food Safety Regulatory Issues