Regulatory Consulting Product List and Ranking from 4 Manufacturers, Suppliers and Companies

Consulting services for the pharmaceutical and medical device industry.

We provide a comprehensive one-stop service from development strategy planning to post-market quality change management and safety management!

Our company leverages its strength in providing a consistent one-stop service, from strategic planning for development to post-marketing quality change management and safety management. We have established a system that allows clients to easily consult with us on all aspects of regulatory affairs, and we will make effective proposals tailored to our clients' needs. We will advance a wide range of business support, including assistance with obtaining manufacturing and sales licenses, post-marketing quality change management, and safety management, while walking alongside our clients. 【Reasons to Choose Us】 ■ Comprehensive backup for all three roles ■ Strategic proposals tailored to clients' needs ■ Reasonable costs and improved operational efficiency ■ Global standard quality *For more details, please download the PDF or feel free to contact us.

Company：キューズコンサルティング
Price：Other

Safety Management
HACCP/GMP compliant
Other Consulting Services

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[Free Consultation Available] Leave your pharmaceutical consulting to us.

Leave the consulting for medical devices and functional foods to us!

Our company provides consulting services for medical devices and related regulatory affairs, including approval application processes for medical devices, in vitro diagnostic products, and functional foods. We also assist with STED preparation, consultations with PMDA, and responses to PMDA inquiries. Additionally, we support the acquisition of business types such as manufacturing and sales, preparation of standard operating procedures, manufacturing, ISO 13485, and sales. We offer regulatory consulting for applications related to medical devices, in vitro diagnostic products, and other bioproducts, ensuring accurate and prompt responses for various PMDA pre-consultations, inquiries, and the preparation of application documents and STEDs. Furthermore, we provide support for the preparation of standard operating procedures and the acquisition of business types related to manufacturing, manufacturing and sales, and ISO 13485, based on precise advice. Please feel free to contact us if you have any requests. 【Features】 ■ 10 years of experience as a regulatory consultant ■ Consulting for over 30 companies ■ 30 years of experience and achievements in the industry ■ For those who wish to "manufacture and sell medical devices," "import and sell medical devices," or "sell functional foods." *Please download the application form as a PDF.

Company：神戸バイオ・デバイス開発研究所
Price：Other

Other Consulting Services
Product Development

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Pharmaceutical Consulting Services

We specialize in providing services to small and medium-sized enterprises!

Our company provides consulting services related to pharmaceutical affairs. Not only do we support the preparation of application documents, but with practical experience in quality control from my previous job, we can offer specific advice on how to address issues from the client's perspective and provide accurate advice on common problems. Please feel free to contact us if you have any requests. 【Service Contents】 ■ Consulting related to the licensing of pharmaceutical business types ■ Consulting related to approval applications, etc. ■ Consulting contracts ■ Consulting related to quality management such as QMS, GVP, GQP, etc. ■ Consulting related to customs procedures for unapproved pharmaceutical products, etc. *For more details, please feel free to contact us.

Company：オールグリーン
Price：Other

Other Consulting Services

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1. Pharmaceutical Consultant 2. Solutions for concerns regarding the import and storage of overseas medical devices

Holding qualifications for manufacturing and sales (D-MAH) as well as manufacturing! We handle everything from the import to distribution of overseas medical devices! We provide comprehensive support from notification to storage!

We provide support services as a Manufacturer and Marketing Authorization Holder (MAH), Designated Marketing Authorization Holder (D-MAH), and Manufacturer (Storage) for overseas medical device manufacturers. ◎ On behalf of overseas medical device manufacturers aiming to enter the Japanese market, we will handle notification and registration tasks. 1. We will apply for permits and notifications to the PMDA/Ministry of Health, Labour and Welfare on behalf of foreign manufacturers. (Foreign manufacturers can directly submit marketing notifications as the notifier. We will assist with this.) 2. We will act on behalf of foreign manufacturers for their manufacturing registration tasks. 3. We will handle correspondence with authorities regarding QMS/GVP. 4. We will respond to the Ministry of Health, Labour and Welfare/PMDA/prefectures. "Third-Class Medical Device Manufacturing and Sales License Number: 28B3X10031" ◎ As a manufacturing registration holder (storage), we will store your medical devices. 1. Temporary storage of imported medical devices (advanced medical devices, controlled medical devices, general medical devices) 2. Please use our warehouse for the packaging, labeling, and storage of your medical devices. We provide comprehensive support from import to distribution. We also accept inquiries regarding pharmaceutical affairs, so please feel free to contact us if you have any questions. *For more details, please download the PDF.

Company：神戸バイオ・デバイス開発研究所
Price：Other

Other Consulting Services
Product Development

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Online salon held on April 4 (Friday) and April 11 (Friday).

We are introducing the Online Salon of the Pharmaceutical Mail Order University!

The pharmaceutical mail-order industry is undergoing intense changes. Starting from April 2025, we will hold an online salon for pharmaceutical mail-order university twice a month on Fridays at 1 PM. This is a paid online salon utilizing ZOOM meetings where participants can learn the latest information on pharmaceutical regulations, health foods, cosmetics, and medical devices, as well as exchange information with each other. Even if you cannot participate live, you can watch the archive. *For detailed information, please refer to the related links. For more details, you can download the PDF or feel free to contact us.

Company：RCTジャパン
Price：Other

Other consumables
Other safety and hygiene products

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