Nyprax Pharma is a rapidly expanding Regulatory Affairs consultancy firm based in Singapore. With over 20 years of experience in the field of Regulatory compliance, we offer expert guidance and consultation ensuring smooth submissions to meet the local regulatory requirements so as to enable your medical devices to be imported, distributed and marketed in Singapore.
Originating from humble beginnings, today Nyprax works with a vast network of medical devices and IVD clients worldwide, from MNCs to SMEs.
Our expertise in Singapore qualifies us as a provider of regulatory and follow-up services in the following categories:
- Medical Device Registration
- In Vitro Diagnostics (IVD) Device Registration
- Pharmaceutical Registration (including New Drug Application (NDA), Biologics and Generics)
- Quality Management Services (QMS) such as GDPMDS (Singapore)
- Cosmetic Notification
- Health Supplement Notification
- Chinese Proprietary Medicines (CPM)
- Logistics service provider and
- Marketing Partner
We provide constant support through every stage of your product development and we guarantee a smooth-sailing process all the way up till the final stage, product approval. Regardless of your medical area of focus, we will ensure a hassle-free registration process in a timely manner, thus maximizing your product’s commercial potential.
We keep well abreast with the current legislation, evolving regulatory requirements, and new industry initiatives. We have extensive experience and knowledge of regulatory affairs, and offer our unwavering support and commitment to meet your regulatory needs.
All our services are offered in-house and not by service partners, ensuring a consistent level of service that is tailored to your firm’s needs, as well as a single point of contact for easy communication.