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