Regulatory

Getting your drug product to market!

Byron Chemical Company works closely with its partners to comply with the necessary submissions that are mandatory during the entire drug approval process.  Our philosophy towards this very general term “regulatory” is quite fundamental.  We recognize, accept, and appreciate that drug regulations are about ensuring the safety of drug products – and we are proud to contribute towards maintaining the high standards of the industry.

Our diligence to meet customer requirements while maintaining compliance with local authorities has rewarded us with confidence to service the pharmaceutical drug markets into the future.

Byron Chemical Company maintains excellent standing with the FDA (Food & Drug Administration), DEA (Drug Enforcement Agency), and other local authorities which regulate the Drug Import & Distribution market. 

At the present time, our regulatory department manages over 120 active DMFs (Drug Master Files) as well as over 24 ANDAs (Abbreviated New Drug Applications) in support of our clients.

Below are typical regulatory and drug import areas which we cover to ensure compliance:
(Left Photo:  CU Chemie Uetikon GmbH, Lahr, Germany)

DMF & ANDAs

Manage DMFs and ANDAs, pre & post approval requirements, including submissions, annual updates, deficiency responses, and other necessary procedures needed to keep these documents current.

Training & Regulatory Compliance

Byron Chemical maintains internal training program for various regulatory functions and authorities including FDA and DEA.  Our suppliers and customers can be assured that the Byron team remains current with the latest cGMP and cGLP (current Good Manufacturing/Lab Practices) guidelines and other relevant practices.    

Regulatory Agents & Representatives

Byron Chemical represents our partners as their official US regulatory agents bridging the gap between the US FDA and our international manufacturing partners. As products expand to world markets, our team is able to assist in various global regulatory approvals as appropriate for our client base.

Audits

We conduct preliminary plant audits of our partner facilities. The scopes of the audits vary as appropriate for the specific client or supplier project.

Document Support & Handling

We provide support for technical packages related to specific dosage or API products as well as site transfer protocols for APIs and ANDAs

Drug Import/Distribution

Byron Chemical Company is licensed and registered to import, store, and distribute pharmaceuticals in the US.  We are a licensed drug wholesaler, and registered with the DEA and FDA.  Our facility is registered to store and distribute specific controlled drugs.

Responsible Care

Byron Chemical takes special care to ensure that drug products do not end up in the wrong hands. The safety and security of drug distribution is the highest priority for Byron Chemical. In addition to our licenses and registrations, our team maintains membership with C-TPAT (Customs-Trade Partnership Against Terrorism). We are pleased to be a member of C-TPAT contributing to the safety of our borders. This is one very important partnership that demonstrates our respect and commitment to continue serving the pharmaceutical drug market, while maintaining our social responsibility.