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Home - Nyprax Pharma
Home - Nyprax Pharma
Home - Nyprax Pharma
Home - Nyprax Pharma
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nypracpharma
nypracpharma
· 07 Apr 2025
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Nyprax Pharma provides specialized regulatory services for the pharmaceutical and medical device industries in Singapore and Malaysia. With over 15 years of experience, the company offers expert guidance in areas like medical device registration, HSA registration, and pharmacy licence registration. Nyprax Pharma also assists in obtaining GDPMDS certification in Singapore, ensuring compliance with regulatory standards. Their comprehensive solutions streamline submission processes and expedite approval timelines, helping clients meet local and international regulatory requirements efficiently.

Our Services
🔒 Independent License Holding
Don’t have a local presence or license yet? No problem!
Nyprax Pharma acts as an independent licence holder, allowing you to legally import, distribute, or market your pharmaceutical products in countries where you don’t yet have a registered office. Our independent license holding service is especially useful for overseas companies looking to enter regulated markets like Singapore, Malaysia, or other ASEAN regions without delays or legal barriers. 🌐

🩺 Medical Devices Registration
Registering medical devices requires a clear understanding of classification rules, technical documentation, and regulatory frameworks such as CE, FDA, or HSA.
Nyprax Pharma assists with:

Device classification and risk analysis

Compilation of technical dossiers

Regulatory submissions and authority liaison

Post-market surveillance and reporting

Whether you’re launching a low-risk diagnostic kit or a high-risk implantable device, we ensure you meet medical device regulatory compliance across all stages. 📑🧪

💊 Pharmaceutical Registration
We streamline the pharmaceutical product registration process to help you launch faster with full regulatory confidence.
Our services cover:

Over-the-counter (OTC) drugs

Prescription medications

Controlled drugs

Biologics and biosimilars

From pharmacy licence registration to dossier preparation and regulatory submission, we help ensure your drug products comply with local and international requirements. ⚖️🌍

📋 Quality Management Services
Regulatory success is rooted in a strong Quality Management System (QMS).
Nyprax Pharma supports businesses with:

GMP, GDP, and ISO compliance

SOP development

Internal audits and gap analysis

Quality documentation and validation

Our QMS experts help you meet stringent global standards, reduce risks, and improve operational efficiency. 🛡️✅

💄 Cosmetics Notification
Bringing a cosmetic product to market? You must notify health authorities and ensure your formulation meets safety and labelling standards.
We help with:

Cosmetic product notification (CPN)

Ingredient safety review

Regulatory labeling compliance

Border clearance support

From skin care to personal hygiene products, we ensure your cosmetics are notified and compliant for safe market entry. 💅🧴

🌿 Health Supplements & Herbals
Launching vitamins, dietary supplements, or herbal remedies? Each product must comply with health regulations related to claims, ingredients, and safety.

Our support includes:

Product classification and formulation review

Regulatory submissions and labeling compliance

HSA, NPRA, and TGA guidance

Scientific substantiation of health claims

We make sure your health supplements and herbals are compliant, well-documented, and ready for distribution. 💚🧠

🧪 Chinese Proprietary Medicine (CPM)
Traditional medicines require modern regulatory strategies.
Nyprax Pharma helps companies register Chinese Proprietary Medicines (CPM) with national authorities, ensuring full documentation and compliance with labeling, safety, and efficacy standards.

We provide:

CPM registration and notification

Ingredient evaluation and formulation support

Label translation and regulatory advice

Compliance with HSA and similar regulators

Preserve tradition while staying fully compliant with modern regulatory requirements. 🏮📜

🔚 Conclusion
Navigating the world of pharmaceutical and health product regulations can be overwhelming—but it doesn’t have to be. With Nyprax Pharma as your trusted regulatory partner, you gain access to a team of experts who are committed to delivering accuracy, efficiency, and peace of mind at every step.

Whether you're launching a prescription drug, medical device, cosmetic product, health supplement, or traditional Chinese medicine, we’re here to ensure your regulatory journey is smooth, compliant, and successful. 💼🌍💡

👉 Ready to simplify your regulatory process and access global markets?
Choose Nyprax Pharma. Your compliance. Our commitment.

Business Address: 116 Changi Rd, #04-05 Wiz@Changi, Singapore 419718
Business Phone: +65 634-804-81

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