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Rede Global de Consultoria em Assuntos Regulatórios

Conecte-se com nossa rede confiável de consultorias em assuntos regulatórios especializadas em registro e conformidade de dispositivos médicos nos principais mercados globais.

Mostrando 2 de 2 consultorias

Registrar Corp

Hampton, Virginia (HQ), Shenzhen, China, London, United Kingdom, Paris, France, Madrid, Spain, Hyderabad, India, Kuala Lumpur, Malaysia, Tel Aviv, Israel, Guatemala City, Guatemala, Cape Town, South Africa

Registro

A global FDA compliance firm assisting businesses in the food, medical device, drug, and cosmetic industries with registration, U.S. Agent services, labeling, and regulatory software solutions.

Especializações

FDA Registration & Renewal
U.S. Agent Services
Labeling & Ingredient Review
MoCRA Compliance (Cosmetics)
Food Safety (FSMA/PCQI)
Detention Assistance
Medical Device Listing (510k assistance)
Drug Establishment Registration
Adverse Event Management

Idiomas: English, Chinese (Mandarin & Cantonese), Spanish, French, German, Italian, Japanese, Korean, Portuguese, Russian, Hindi, Arabic, Thai, Vietnamese, Indonesian

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ARQon Pte. Ltd.

Singapore (HQ), Malaysia, Vietnam, Indonesia, Philippines, Thailand, Taiwan, Hong Kong, South Korea, Switzerland, USA, Australia, New Zealand, Rwanda, India, Sri Lanka

Registro

We are a premier regulatory consultancy firm specializing in medical devices, in-vitro diagnostics (IVD), and pharmaceuticals. Founded in 2014, the company offers a comprehensive suite of services ranging from product development strategy and clinical trials to product registration and post-market surveillance. With a team of experts possessing vast experience in regulatory authorities and industry, we bridge the gap between scientific innovation and regulatory compliance, ensuring patient safety while fostering medical advancement. The company also provides unique business matching services through its ATTOPOLIS platform and training through the International Medical Device School.

Especializações

Medical Device Product Registration
In-Vitro Diagnostics (IVD) Registration
Drug & Cosmetic Registration
Quality Management Systems (ISO 13485, GDPMDS)
Clinical Trials & Evaluation
Local Authorized Representative
License Holding
Global Market Strategy
Distributor Search (ATTOPOLIS)

Idiomas: English, Chinese (Mandarin), Malay, Vietnamese, Thai, Korean, German

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