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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.
  • REACH: Compliance consultants related to European regulations for the Registration, Evaluation, Authorization and Restriction of Chemicals, new human health and the environmental guidelines for chemicals instituted in June 2007.
  • 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

Consultant Number: 1448, Process Chemical Engineer Expert in Isocyanate, Diisocyanate and Polyurethane Manufacturing

Consultant Number: 371, Polymer Chemist Consultant: Thermoplastics, Bio-based Polymers, Water Soluble Polymers and REACH Compliance

Consultant Number: 1488, Environmental Risk Assessments Consultant and Expert Witness for Agricultural and Industrial Chemicals


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 Analytical Chemist: QA/QC, Validation and FDA Compliance

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: 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

Consultant Number: ,

Consultant Number: 1479, International Contract Manufacturing Consultant -- Cosmetics and Pharmaceuticals

Consultant Number: 1461, Pharmaceutical Consultant Specializing in Cardiovascular Drug Development, Drug Safety and Medical Writing

Consultant Number: 1484, Consultant in Biotechnology and Pharmaceutical Research and Development: New Drug Discovery, F.D.A. Filings, Patent Evaluation and Litigation

Consultant Number: 1393, Pharmaceutical Compliance Consultant: FDA Regulations & Submission with Management Experience at Indian Pharmaceutical Companies

Consultant Number: 1488, Environmental Risk Assessments Consultant and Expert Witness for Agricultural and Industrial Chemicals

Consultant Number: 1565, Pharmaceutical Drug Product and API Consultant: GMP Auditing, Managing Auditing Teams and International GMP Auditing Expertise

Consultant Number: 1593, Medical Device Quality System Consultant Specializing in FDA QSR, ISO 13485 and ISO 9001

Consultant Number: 1620, Analytical, CMC and Specification Consultant for Pharmaceutical Drug Substance and Drug Product Development

Consultant Number: 1563, FDA Regulatory Consultant Specializing on Medical Devices


OSHA

Experts in OSHA regulations and compliance to ensure a safe and healthy work environment.

Consultant Number: 19, Safety Consultant and 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

Consultant Number: 1448, Process Chemical Engineer Expert in Isocyanate, Diisocyanate and Polyurethane Manufacturing

Consultant Number: 1508, Chemical Consultant Expert in China Chemical Commerce


REACH

REACH is the European Community Regulation on chemicals and their safe use. REACH is an abbreviation for the Registration, Evaluation, Authorization and Restriction of Chemical substances. REACH regulations aim to protect and improve human health and the environment with early identification of troublesome chemical substances and materials. REACH system were implemented in Europe in June 2007 and the benefits of the regulations will come gradually as more and more substances are phased into REACH.

Consultant Number: 1488, Environmental Risk Assessments Consultant and Expert Witness for Agricultural and Industrial Chemicals

Consultant Number: 1505, Analytical Chemistry Consultant Specializing in Laboratory Problem Resolutions, Polymer Chemistry and cGMP Auditing

Consultant Number: 371, Polymer Chemist Consultant: Thermoplastics, Bio-based Polymers, Water Soluble Polymers and REACH Compliance


Toxicology / TSCA

The identification, remediation and safe handling of toxic materials and biologically active agents.

Consultant Number: 621, Toxicologist Consultant: OTC Drugs, Pharmaceuticals, Cosmetics and Personal Care Products

Consultant Number: 637, Toxicology Consultant

Consultant Number: 16, Chemical Process Safety Analysis 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

Consultant Number: 1579, Fire and Explosion Consultant and Expert Witness: Combustion Equipment, Flue Gas Systems and Process Equipment