A Full Service Active Pharmaceutical Ingredient Supplier

REGULATORY & Technical Services

The key to chemwerth's success is our full range of regulatory services. chemwerth's experienced in-house Seminar regulatory group maintains an active channel of communication with both the FDA and the USP committees. We have 16 full-time chemwerth regulatory employees based in Connecticut and Shanghai performing original Regulatory submission work all over the world as well as all aspects of Regulatory maintenance. In addition, chemwerth's Regulatory team performs cGMP audits our represented manufacturers twice annually using chemwerth's FDA Quality Systems program. We do not hire outside consultants because chemwerth has a vested interest in ensuring that both our API manufacturers and Finished Dosage customers obtain the necessary results to meet FDA Regulatory and cGMP compliance requirements.

Our close association with our represented manufacturers enables us to respond quickly and reliably to all aspects of regulatory submissions, cGMP issues, quality assurance issues and technical service requests. Our experience, knowledge, and good working relationship with the FDA help us to expedite regulatory approvals.

chemwerth, in coordination with our manufacturers, prepares and distributes extensive technical packages to support your product development. We also aid in establishing specifications and test methods that are mutually acceptable to the demands of our Customers and Regulatory Agencies.



		REGULATORY & Technical Services The key to chemwerth's success is our full range of regulatory services. chemwerth's experienced in-house regulatory group maintains an active channel of communication with both the FDA and the USP committees. We have 16 full-time chemwerth regulatory employees based in Connecticut and Shanghai performing original Regulatory submission work all over the world as well as all aspects of Regulatory maintenance. In addition, chemwerth's Regulatory team performs cGMP audits our represented manufacturers twice annually using chemwerth's FDA Quality Systems program. We do not hire outside consultants because chemwerth has a vested interest in ensuring that both our API manufacturers and Finished Dosage customers obtain the necessary results to meet FDA Regulatory and cGMP compliance requirements. Our close association with our represented manufacturers enables us to respond quickly and reliably to all aspects of regulatory submissions, cGMP issues, quality assurance issues and technical service requests. Our experience, knowledge, and good working relationship with the FDA help us to expedite regulatory approvals. chemwerth, in coordination with our manufacturers, prepares and distributes extensive technical packages to support your product development. We also aid in establishing specifications and test methods that are mutually acceptable to the demands of our Customers and Regulatory Agencies.