Industries:

  • Pharmaceutical
  • Chemical
  • Food/Nutritional
  • Medical Device

Services:

  • Compliance Training
  • Import Holds & Detentions
  • Agreements: Quality, Distribution, Non-Disclosure, as well as others
  • Assist companies in building a Regulatory Department in-house
  • Drug Establishment Registration & Product Listing
  • Food Establishment Registration¬†
  • Inspectional FDA 483 import issues (product codes, holds, detentions)
  • HACCP (Hazard Analysis and Critical Control Points)
  • TSCA (Toxic Substances Control Act) Submissions and Records
  • Regulatory submissions including Medical Device Q-Submissions, Drug Master Files, as well as others

Other Regulatory Matters:

Areas include regulatory matters under the following agencies:

  • United States Department of Agriculture
  • Environmental Protection Agency
  • Customs and Boarder Protection
  • Department of Homeland Security
  • Drug Enforcement Agency

Mediation:

  • Business Related Disputes
  • Contract Disputes

And the rest of it:

Compliance matters affect businesses in other areas besides those listed on this services page.  ELINA KHACHIYAN CONSULTING, LLC may undertake compliance projects outside of the listed services, where appropriate.

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