Please proceed to the dedicated web page for each for more detailed information by clicking on the title of interest.
Process Analytical Chemistry (PAC / PAT)
On-line analysis performed directly upon a pharmaceutical or chemical process can be used to control the process via feedback through an existing DCS or PLC system. This results in increased product quality, reduced raw material usage and waste generation, increased process yield, & lower operational cost.
We provide chemical and pharmaceutical process assessment, guidance on optimum analyzer selection, and analyzer project management through the implementation phase, as needed. We also provide assessment and correction of problematic laboratory analytical methods.
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Educational Materials Development
The continuing education of employees is critical to their success in producing high quality products to ensure the ongoing profitability of their companies. This is best addressed through the use of on-site short courses enabling employees to be trained economically with minimal time away from the job.
We can deliver the PAT short course originally developed for the American Chemical Society on-site at low cost to any size group of employees. We have also produced another short course for the USP on excipient quality and supply chain integrity.
Pharmaceutical cGMP Supplier Auditing
We perform 1-3 day on-site audits of the key operations and documentation of clients’ suppliers according to the 21 CFR part 211 or part 111 regulations. We employ a very comprehensive questionnaire and produce highly detailed audit reports with completed corrective action request forms for observations, as needed.
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Drug Master File (DMF) Services
Our firm offers DMF development based upon the Common Technical Document format as well as annual maintenance services. Conthera Pte Ltd. / Simplyceutics (Singapore) has been retained to act as our firm's agent to directly interface with all interested clients in the Asian region.
