ElendiLabs Logo

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 5 de 5 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

Ver Perfil

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

Ver Perfil

Regulatory Compliance Associates Inc. (RCA)

Pleasant Prairie, WI, Tampa, FL

Registro

Regulatory Compliance Associates (RCA) is a leading global provider of regulatory and compliance expert consulting services for life science companies. The company offers expertise in regulatory affairs, assessments and audits, agency response, preparation and remediation, and new product development support for medical devices, pharmaceuticals, and compounding pharmacies.

Especializações

Medical Device Consulting
Pharmaceutical Consulting
Compounding Consulting
Regulatory Affairs
Quality Assurance
Audits and Assessments
New Product Development

Idiomas: English

Ver Perfil

Emergo by UL

USA, Canada, Brazil, Australia, China, Hong Kong, Taiwan, India

Registro

A dedicated partner for medical device and IVD manufacturers, we offers deep local regulatory expertise through its offices in over 20 global locations. Services include product registration, human factors research, clinical strategy, and local in-country representation to ensure rapid, compliant market access worldwide.

Especializações

Idiomas: English, Chinese (Mandarin & Cantonese), Japanese, Korean, Spanish, Portuguese, German, French

Ver Perfil

Pacific Bridge Medical

USA, China, Japan, Singapore, Hong Kong, India (Affiliate), Indonesia (Affiliate), Korea (Affiliate), Malaysia (Affiliate), Philippines (Affiliate), Taiwan (Affiliate), Thailand (Affiliate), Vietnam (Affiliate)

Registro

A boutique consulting firm specializing in Asian medical and pharmaceutical regulatory affairs and business development. We provide comprehensive, on-the-ground support for market entry, registration, quality compliance, and local agent representation across 12 Asian markets.

Especializações

Regulatory Strategy
Product Registration
Market Access/Reimbursement/Health Economics
Quality Compliance
Local Agent Representation
Clinical Trials
Business Strategy
Distributor Search
Sourcing & Manufacturing
Acquisitions, Joint Ventures, & Licensing
Recruiting

Idiomas: English, Japanese, Chinese (Mandarin & Cantonese), Korean, Thai, Vietnamese, Bahasa Indonesia, Bahasa Malaysia

Ver Perfil

Junte-se à Nossa Rede de Consultoria

Você é uma consultoria em assuntos regulatórios especializada em dispositivos médicos? Junte-se à nossa rede global e conecte-se com fabricantes que buscam orientação especializada.