About the Company
In the past 20 years, Chinese chemical and pharmaceutical companies have made significant progress in the global market. As of today, China is already the world largest market for chemical products, and the biggest producer and exporter of various Active Pharmaceutical Ingredients. In the recent 3 years, Chinese pharmaceutical companies are further forging into global Finished Dosage Form (FDF) market. The number of Chinese pharmaceutical firms that have been inspected by the US FDA, and approved to export finished pharmaceutical products into the United States, is increasing day by day.
However, due to a language barrier, information asymmetry, and education difference, many Chinese companies are having difficulties grasping the concepts in Western quality culture, catching up with the changing regulatory landscape, and coping with oversights from overseas regulatory bodies. The aforementioned problems are imposing significant business risks and uncertainties, eroding profitability of the exporting businesses, and hurting the bottom-line of Chinese pharmaceutical manufacturers and exporters.
Typical problems are:
Amreg provides Chinese companies with the most current regulatory requirements and product approval strategies,as well as economical quality and registration solutions to help mitigate regulatory risks, meet regulatory compliance at minimum costs, and adjust to the evolving regulatory landscape. Our goal is to help you build a sustainable and profitable exporting business in the most highly regulated markets (USA, Canada, and Europe).
However, due to a language barrier, information asymmetry, and education difference, many Chinese companies are having difficulties grasping the concepts in Western quality culture, catching up with the changing regulatory landscape, and coping with oversights from overseas regulatory bodies. The aforementioned problems are imposing significant business risks and uncertainties, eroding profitability of the exporting businesses, and hurting the bottom-line of Chinese pharmaceutical manufacturers and exporters.
Typical problems are:
- Taking measures that are not addressing the concerns from the regulatory bodies (thus adding unnecessary business costs)
- Building QA systems that are not capable of managing and controlling quality risks (thus unable to sustain export business and maintain market share)
- Writing SOPs that are not practical, difficult to be understood, reviewed and audited by an inspector (leading to failures in audits and inspections, causing disruption and setbacks in export volumes)
- Attempting to follow various guidelines and guidance documents, but incapable of understanding the rationale behind them (and hence not being able to create a consistent and robust quality system and registration dossier, causing quality disputes, and hurting reputation)
- Misinterpreting FDA communication, including deficiency letters and inspection observations, which leads to inappropriate and unsatisfactory responses and results in delayed product and facility approval
Amreg provides Chinese companies with the most current regulatory requirements and product approval strategies,as well as economical quality and registration solutions to help mitigate regulatory risks, meet regulatory compliance at minimum costs, and adjust to the evolving regulatory landscape. Our goal is to help you build a sustainable and profitable exporting business in the most highly regulated markets (USA, Canada, and Europe).