Industries:
- Pharmaceutical: Including anyone in the supply chain such as manufacturers of finished products, Active Pharmaceutical Ingredients (API), intermediates, and excipients, as well as importers, distributors, storage facilities, third party logistics providers, testing laboratories packagers, and labelers.
- Chemical: Including importers, distributors, storage facilities, third party logistics providers.
- Food/Nutritional: Including anyone in the supply chain such as manufacturers of food, nutritional, dietary ingredients as well as finished product manufacturers, importers, distributors, storage facilities, third party logistics providers, testing laboratories packagers, and labelers.
- Medical Device: Including anyone in the supply chain such as manufacturers, importers, distributors, storage facilities, third party logistics providers, testing laboratories packagers, and labelers.
Services:
- Compliance Training: Do you already have a regulatory team in place but just need them to get trained in a particular area? Or are you just starting to put together a regulatory team and need help getting the right people in place and need help training those people? Or do you just need a companywide training on a particular regulatory topic? Well you have come to the right place for all those needs.
- Import Holds & Detentions: Including communicating with the FDA, or any other interested Agency to get your product released in a timely and cost effective manner, assisting you in figuring out and providing the proper information from the start to avoid holds and detentions, as well as assisting you in compiling the proper information to resolve hold and detention related matters.
- Contracts & Agreements: Including the drafting and review of Manufacturer and Warehousing Quality Agreements which are both FDA compliant and compliant with Health Canada, Supplier Distribution Agreements, Non-Disclosure/Confidentiality Agreements, as well as others. These Agreements run up and down the supply chain, so it is best to have a lawyer who is knowledgeable in the chemical and FDA regulated industries to review and draft them to ensure certain provisions are included and to ensure a legally sound document.
- Assist companies in building a Regulatory Department in-house: Often times smaller companies or new companies do not have a Regulatory Department and need to build one. This service allows an attorney to come into your company, learn the nature of your day to day operations, determine which agency regulations your company is subject to, train your staff in those regulatory requirements, assist in implementing these requirements and leave you with a stable and functioning Regulatory Department.
- Drug Establishment Registration, National Drug Code (NDC) registration & Product Listing: The FDA requires certain operations to register with the Agency, register their products NDC numbers and list the products handled at the facility. This can be a complicated and time consuming task. Through this service, you can either have your staff trained in these processes or these processes may be done on your behalf.
- Food Establishment Registration: The FDA requires food facilities to register with the Agency. This can be a complicated and time consuming task. Through this service, you can either have your staff trained in these processes or these processes may be done on your behalf.
- Inspectional FDA 483: In the event your facility is about to undergo an inspection or whether you have already undergone an inspection and received an FDA Form 483, through this service an attorney will help you prepare for an inspection in a way to potentially avoid an FDA Form 483 issue, or will assist you in answering the 483, preparing a Corrective Action Plan to address the observations, and assist in implementing the plan for a successful follow up visit.
- HACCP (Hazard Analysis and Critical Control Points): As part of the Food Safety Plan of the company, a company may need to have a HACCP Plan in place. This service assists you with putting together a sound HACCP Plan and helps you with implementing it within your company.
- TSCA (Toxic Substances Control Act) Submissions and Records: If you are a company handling chemicals then you are likely familiar with TSCA and all the provisions under it, relevant to your company. However, if you are unsure, or need assistance figuring out whether you are subject to TSCA and which provisions within TSCA, or need assistance implementing the TSCA requirements, this service will assist you in those areas.
- Regulatory submissions including Medical Device Q-Submissions, Drug Master Files, as well as others: Regulatory Submissions come in all shapes and sizes and are different depending on the agency you are subject to and the operation you are partaking in. This service assists you with putting your submission together and helping you identify any areas of improvement to set you submission up for a positive outcome.
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
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