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 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.