Regulatory Compliance
Regulatory Compliance basically means following the rules set by the government: Federal, State, Local or international treaty. For CECON consultants, regulatory expertise generally falls into these three broad categories:
FDA: Regulations related to food, drugs and cosmetics and all issues associated with the materials, equipment, testing and packaging of these materials.
OSHA: Consulting expertise on workplace safety, hazards and health and compliance with all regulations of the Occupational Safety and Health Administration.
TSCA: Experts on materials toxicity and compliance with the Toxic Substances Control Act.
EPA: Consulting related to compliance with regulations of the Environmental Protection Agency.
In FDA compliance work, CECON specialists provide expertise that can:
Prepare and review of CMC section of IND, NDA and ANDA.
Prepare a master drug file (MDF).
Establish USP liaison and Compendial Method Development .
Prepare or assist in the Medical Devices 510(k) registration.
QA/QC systems development and management according to FDA regulations.
Validation of manufacturing process, equipment cleaning and software.
Analytical laboratory certification.
Assist in cGMP, GLP and GCP compliance.
Pre approval inspection and preparation qualification of facilities and equipment in IQ / OQ / PQ
Training per cGMP.
While FDA experts are the largest part of CECON's Regulatory Compliance practice, we do have many consultants specializing in the environmental, work place safety, and the hazards of materials, material handling, and the toxicity of materials.
Following are selected consultants that are skilled in regulatory compliance issues, listed by specialty. Many other similar experts are in our Expertise Data Base. Contact a CECON specialist to help identify technical experts who exactly meet your needs.
EPA
Regulatory and standards experts related to the Environmental Protection Agency and many Federal and State EPA Statutes.
Consultant Number: 724, Chemical Process Engineer: Environmental Remediation
Consultant Number: 292, Environmental Regulations Consultant and Hazardous Waste Management
Consultant Number: 1023, Expert Witness and Pesticide Consultant Specializing in Pesticide Regulations, Environmental Investigations and Consumer Safety
Consultant Number: 1194, Consultant Chemical Engineer for Industrial Chemical Processes and Products Including Oxidizers, Phosphorus and Sodium Carbonate
Consultant Number: 1227, Diesel Engine Technologies: Consultant and Expert Witness
Consultant Number: 1012, Pesticide Regulation Consultant
Consultant Number: 1385, Groundwater and Soil Remediation Consultant
Consultant Number: 1396, Wastewater Treatment Consultant
Consultant Number: 978, Air and Water Pollution Emission and Regulatory Consultant
FDA
Experts on Food and Drug Administration regulations and standards, particularly for pharmaceuticals, medical devices and food.
Consultant Number: 1139, Certified Safety Professional and Trainer
Consultant Number: 1166, Pharmaceutical Laboratory, QA/QC, Validation and Stability
Consultant Number: 1116, Biochemical Consultant for Designing and Equipping Medical Research Laboratories
Consultant Number: 1124, FDA Consultant and Procurement and Sourcing Expert
Consultant Number: 687, Regulatory, FDA & Pharmaceutical Chemist
Consultant Number: 935, Validation Protocols for Analytical Equipment
Consultant Number: 1164, Consultant in International Pharmaceutical Processing, Production, Manufacturing, Packaging, and Facility Design, Relocation, Startup and Shutdown
Consultant Number: 959, Bioengineer Consultant Expert in Material Science, Nanotechnology, Biosynthesis of Polymeric Materials, Biomaterial Implants and Drug Delivery
Consultant Number: 1045, Biotechnology Consultant
Consultant Number: 1231, Pharmaceutical Chemist Consultant for Drug Analysis, Validation and Quality Control
Consultant Number: 1258, Canadian Regulatory Affairs Quality Control Expert for Pharmaceuticals and Medical Devices
Consultant Number: 1391, Medical Device Consultant and Expert Witness Specializing In Silicone Based Materials
OSHA
Experts in OSHA regulations and compliance to ensure a safe and healthy work environment.
Consultant Number: 19, Safety Expert Witness
Consultant Number: 1139, Certified Safety Professional and Trainer
Consultant Number: 292, Environmental Regulations Consultant and Hazardous Waste Management
Consultant Number: 1215, Civil Engineer and Construction Expert Witness for Structural Design of Pharmaceutical, Chemical and Food Plants
Consultant Number: 1226, Chemical Engineer Consultant: Hazard Chemicals Manufacture; Expert for Glycolic Acid Production
Consultant Number: 1276, Industrial Hygiene, Worker Safety and Regulatory Compliance Consultant and Expert Witness
Consultant Number: 1343, Regulatory Consultant: TSCA, FIFRA and OSHA Hazard Communications
Consultant Number: 1314, Hazardous Waste Management and Remediation Consultant
Consultant Number: 985, Hazardous Waste and Toxic Chemical Regulating Consultant
Consultant Number: 1303, Toxicology and Occupational Exposure Consultant and Medical Doctor
Consultant Number: 1397, Registered Professional Industrial Hygienist and Expert Witness
Consultant Number: 1399, Safety Consultant: Fuel Transportation, Oil Refineries, Retail Gasoline and OSHA Compliance
Toxicology / TSCA
The identification, remediation and safe handling of toxic materials and biologically active agents.
Consultant Number: 621, Toxicologist
Consultant Number: 637, Toxicology Consultant
Consultant Number: 16, Safety Consultant
Consultant Number: 1023, Expert Witness and Pesticide Consultant Specializing in Pesticide Regulations, Environmental Investigations and Consumer Safety
Consultant Number: 868, Forensic Medicine Toxicologist, Researcher, Caseworker, Expert Witness
Consultant Number: 1260, Pesticide Expert: Good Laboratory Practice Studies and Analyzes Environmental Trace Organics
Consultant Number: 1343, Regulatory Consultant: TSCA, FIFRA and OSHA Hazard Communications
Consultant Number: 1303, Toxicology and Occupational Exposure Consultant and Medical Doctor
Consultant Number: 1012, Pesticide Regulation Consultant
Consultant Number: 985, Hazardous Waste and Toxic Chemical Regulating Consultant