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Regulatory Support

BioKey, Inc. provides a variety of regulatory services tailored to your needs. Customers receive prompt, knowledgeable assistance on projects of any size. Regulatory support services include proofreading and regulatory review of submission documents related to formulation development, clinical trials, marketed products, generics, nutraceuticals and OTC products. Training presentations on the topics listed are also available upon request.

Electronic Submissions (eCTDs)

Submit INDs, NDAs, ANDAs, and DMFs to the FDA compliant with new electronic submission guidelines. BioKey provides regulatory consulting in addition to outsource services for the entire lifecycle of your project. Let us partner with your on your next full submission package.

Paper Applications (CTD)

Compile, author, review and submit applications. Submit paper submissions or hybrid paper submissions including electronic components. BioKey is experienced in both the eCTD and CTD formats and will help prepare your submission package in the format you choose.

Structured Product Labeling (SPL)

Prepare your labeling with document markup standard approved by Health Level Seven (HL7) and adopted by the FDA. BioKey can amend current labeling or help create new SPL labeling.

Establishment Registration

Register your manufacturing, analytical, packaging, distribution facility accordance with 21 CFR 207 through the FDA Electronic Gateway (ESG) submission platform. Must be renewed annually and updated when information changes.

Drug Listing

Submit and update your drug registration and listing electronically (eLIST) using the FDA Electronic Gateway (ESG) submission platform.

U.S. Agent Services
BioKey has a multi-lingual staff that can provide US Agent Services. Foreign manufacturers whose drugs are imported or offered for import into the United States are required to register an agent in accordance with 21 CFR 207.   The agent shall be the designated FDA contact person on behalf of the foreign establishment and will respond to questions regarding products being imported to the United States among other things.

If your particular need is not in the list of services, please contact us for questions or assistance.