Supplier Qualification

We assist our clients in identification and qualification of potential sourcing opportunities or value added alternatives for pharmaceutical products from Asia. We conduct quality and social accountability audits as part of due diligence; resolve compliance issues or technical problems; manage CAPA implantation, and provide manufacture oversight; all aiming to ensure high quality contract manufacturing for successful commercialization. We can also execute for-cause audit on your behalf against specific regulations, procedures or standards in the targeted quality systems (e.g., production, labeling, QC, etc.). Our analytical testing service (see Supply Chain Services) can serve as the third party to provide impartial confirmation testing that can be used for arbitration when needed.

Compliance Education

We provide pharmaceutical quality and compliance related training to the Asian Pacific pharmaceutical manufacturers, a majority of which is at the beginning of a learning curve. We assist our clients to inculcate and sustain quality culture that is critical for an Asian supplier beyond its cost of goods sold (COGS is irrelevant if the company cannot produce an acceptable product). We conduct hand-holding at our clients’ request necessary to make sustainable quality for critical supplies. As the interpretation and application of GMP requirements varies depending on the type of product and phase of the development, we work with our clients to develop an optimal fit within a reasonable budget for suppliers’ quality systems, process, facilities, procedures and controls in view of project priorities and complexities.

Regulatory Dossier Submission

We assist our clients to meet regulatory dossier requirements across the product life cycle such as filing DMF, ANDA or NDA with US FDA, or variations with EMA. We support our clients in delivering high quality regulatory documents, and help prepare our clients for agency’s questions after submissions. We assist you with CMC (Quality) dossier development, manufacturing change or amendment submissions (PAS, CBE, Variations, etc.). For new drugs, during clinical development we support with the review of Efficacy and Safety data. Our team provides clients with regulatory strategy for the entire pipeline throughout clinical development and following approval of the product. We also maintain the product on the market in accordance with all regulatory requirements.