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Manufacturing Outsourcing Support Service

Manufacturing Outsourcing Support Service

To Companies Considering Outsourcing Compound Manufacturing – Spot Support Available as Needed

We provide support in contract and legal matters for companies considering outsourcing manufacturing or utilizing CDMOs. Leveraging our experience in pharmaceutical manufacturing and research, we can offer assistance such as: ・Drafting and reviewing manufacturing outsourcing agreements (including confidentiality agreements) in Japanese and English ・Regulatory compliance checks for the compounds to be manufactured (Pharmaceutical and Medical Device Act, Chemical Substances Control Law, Poisonous and Deleterious Substances Control Act, etc.) ・Support in selecting contract partners and advice through to contract conclusion, if necessary We offer flexible services related to manufacturing outsourcing, tailored to the specific needs and requests of our clients.

  • Legal

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Pharmaceutical Compliance Support Service

Pharmaceutical Compliance Support Service

Pharmaceutical Doctor Support! One-stop assistance for pharmaceutical business operations, including compliance with the Pharmaceutical and Medical Device Act, the Poisonous and Deleterious Substances Control Act, and health food regulations.

We provide consistent support for complex pharmaceutical regulations such as the Pharmaceutical and Medical Device Act and the Poisonous and Deleterious Substances Control Act, through administrative scriveners with backgrounds in pharmacy and drug development experience. With "practical support that can be used in the field," which understands both technology and regulations, we help create an environment where you can focus on your core business with peace of mind. We handle the following types of services: • Support for manufacturing and sales permits and notifications for pharmaceuticals, quasi-drugs, and cosmetics • Support for regulatory compliance related to health foods (so-called supplements, etc.) • Applications and procedures related to the handling of poisonous and deleterious substances • Consulting on related regulations such as the Pharmaceutical and Medical Device Act, the Poisonous and Deleterious Substances Control Act, and the Food Labeling Act Our target fields include pharmaceuticals, cosmetics, quasi-drugs, and health foods. We receive many inquiries from companies that do not have dedicated personnel for pharmaceutical affairs and from startup companies that feel uncertain about regulations.

  • Legal

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Chemical Substance Management Support Service

Chemical Substance Management Support Service

Chemistry professionals are here to help! We support chemical substance management with technology and legal expertise, from export classification and SDS creation to IUPAC naming.

At Pharma Administrative Scrivener Office, we specialize in providing practical support for chemical substance management. Leveraging years of experience in compound research and chemical substance management at pharmaceutical companies, we can address the following needs: • Consulting on relevant regulations such as the Chemical Substances Control Law, Industrial Safety and Health Law, Poisonous and Deleterious Substances Control Law, and Export Trade Control Order • Creation of Safety Data Sheets (SDS), including English and Japanese translations • Creation of IUPAC names and verification of CAS numbers • Assignment of HS codes • Determination of applicability and creation of non-applicability certificates for chemical substances based on the Export Trade Control Order Our "science-oriented administrative scriveners," who can handle everything from structural formula interpretation to system operation, provide accurate document preparation and advice tailored to practical needs.

  • Legal

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