65- 9389 9604

   kennar@singnet.com.sg

Medical Device & Pharmaceutical Regulatory Consultants

Nyprax Pharma is dedicated in providing high quality regulatory services & products accompanied with trustworthy service.


MEDICAL DEVICES

We perform a range of activities for the registration of medical devices such as managing documentation dossiers, collation and submission and managing correspondence with the ministry.


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PHARMACEUTICALS

We provide regulatory support of new chemical entity development, clinical trials, marketed products, generics, OTC products, medical devices, as well as regulatory activities related to mergers and acquisitions. We offer medical and clinical consulting of various aspects of drug development.


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QUALITY MANAGEMENT SERVICES

We provide full support in developing and implementing an effective quality management system for the distribution of medical devices bringing your company in line with the Good Distribution Practice for Medical Devices (GDPMDS).


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COSMETICS

We provide regulatory support including cosmetic notification and labelling claims . We help you ensure that only allowable ingredients are contained in the formulation. We review the permitted preservatives, UV absorbers and colourants used in the cosmetic.


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Health Supplement Notification

Health Supplement Notification

Dealers of health supplements are required to comply with the guidelines for health supplements as set out by the health authority. We ensure that your products comply with the local safety and quality specifications, including meeting the microbial limits, avoiding prohibited/restricted ingredients and knowing the limits and cautionary statements that are mandatory for certain ingredients.

Dealers of health supplements are required to comply with the guidelines for health supplements as set out by the health authority. We ensure that your products comply with the local safety and quality specifications, including meeting the microbial limits, avoiding prohibited/restricted ingredients and knowing the limits and cautionary statements that are mandatory for certain ingredients.

Chinese Proprietary Medicines (CPM)

Chinese Proprietary Medicines (CPM)

Singapore Health Sciences Authorities makes it mandatory for CPMs to be listed with them. For successful approval, requirements such as correct labeling and specifications, valid quality certificates and prior tests conducted on the product must be met.

Singapore Health Sciences Authorities makes it mandatory for CPMs to be listed with them. For successful approval, requirements such as correct labeling and specifications, valid quality certificates and prior tests conducted on the product must be met.