PMDA Regulatory Submissions for In Vitro Diagnostic (IVD) Products and Related QMS Services
DSOはIVDと化粧品にFocusして薬事申請を支援いたします。
基礎研究→処方設計→申請ストラテジー策定→非臨床試験→臨床試験→薬事申請→QMS(ISO13485、厚生労働省令第169号)対応→cGMP製造→マーケ・営業まで一気通貫でPMをお任せください。博士号を有する薬剤師、医師、研究者からなる熟練のコンサルタントチームが貴社を誠心誠意サポートします。
DSO is providing regulatory support focused on PMDA Submission of IVDs and Cosmetics.
Leave your project management to us—from basic research, formulation design, regulatory strategy, nonclinical and clinical studies, and Regulatory submissions to QMS (ISO 13485 and MHLW Ordinance No. 169), cGMP manufacturing, marketing, and sales.
Our experienced team of Ph.D. scientists, pharmacists, and physicians provides comprehensive, dedicated support throughout your project.
CMC Research and Development, Including CMC Regulatory Submissions to FDA and PMDA
通常製剤の設計、試験し、PMDA並びにFDAへのCMC申請までサポートいたします。
もちろん、ご希望があればDSOの有する薬理、安全性、ADME、製剤学の知識・経験からAPIの最も望まれるPK Profileを設定した上で、理想的なPK挙動を示す様な製剤を設計し、PMDA並びにFDAへのCMC申請までサポートいたします。
We support formulation design, testing, and CMC submissions to the PMDA and FDA.
If required, our experts in pharmacology, safety, ADME, and formulation science can define the optimal PK profile for your API and design a formulation to achieve the desired PK performance, followed by full support for PMDA and FDA CMC submissions.
Regulatory Check of Documents of Cosmetics, Pharmaceuticals, and Supplements for Advertising in Japanese Market and Regulatory Submission to Japanese Authorities
DSOはYMAA/KTAA認証された薬剤師による化粧品広告の薬事・法規チェックを格安で提供します（弁護士による最終チェックも含まれます）。
またDSOはCTD Module 3〜5等の医薬品開発文書を、CTD申請経験豊富な薬剤師が薬事・Regulatory Review致します。なお、臨床部分は博士号を有する医師がReviewします。
DSO provides affordable regulatory and compliance reviews of cosmetic advertising by YMAA/KTAA-certified pharmacists, including legal review by attorneys.
DSO also provides Regulatory Review of pharmaceutical development documents, including CTD Modules 3–5, by experienced pharmacists with extensive CTD submission experience. Clinical documents are reviewed by physicians with doctoral degrees.
English, Japanese, French, Korean, and Chinese Language Courses for Medicine, Biotechnology, and Pharmaceutical Development
Native Speakerまたは長期海外滞在歴のある博士号を有する医師、理学博士、または薬剤師がトピックに応じた言語をオンラインで教育訓練します。教育訓練の目的は「綺麗な外国語」を覚えることではありません。目的は「医薬品を始めとしたMedical Productsの臨床、または非臨床開発において３か月後から使える外国語」を身に着けることです。詳細はLanguages Detailsまでご質問ください。
DSO’s On-Line language training is provided by native speakers or internationally experienced Physicians (Ph.D.), Ph.D. Scientists, and Pharmacists, selected according to the topic.
Our goal is not to teach “beautiful” foreign languages. We teach practical language skills that you can use within three months in clinical and nonclinical development of pharmaceuticals and other medical products.
For more information, please contact Languages Details.
RA, QA, and QMS Training in Japan in English and Japanese, Including ISO 13485 and Japan’s QMS Ordinance (MHLW Ministerial Ordinance No. 169), as well as Related Education and Professional Training Services
DSOは日本人にとって難解なISO13485、並びに非日本人にとって難解な厚生労働省令169号をオンラインにて教育訓練します。目的は担当役員、総括製造販売責任者、品質保証責任者、国内品質業務運営責任者（国内品責）等の担当部課長としてMedical Productsの製造販売業を維持できることです。
更にDSOはIVDの申請戦略構築法をオンラインにて教育訓練します。目的はIVD開発のPMの育成です。
DSO provides online training on ISO 13485 for Japanese professionals and Japan’s MHLW Ordinance No. 169 for international professionals. Our goal is to develop professionals capable of managing and maintaining Medical Product Marketing Authorization Holder operations as executives, General Marketing Supervisors, Quality Assurance Managers, Domestic Quality Operations Managers, and department managers.
DSO also provides online training on IVD regulatory submission strategy, with the goal of developing skilled IVD development Project Managers (PMs).
Global Expansion of “UCHINOYA,” Authentic Japanese Cuisine Combining Japanese Science, Technology, and Tradition, with a Two-Year Shelf Life Without Refrigeration or Freezing
和食は日本の誇りです。そして科学技術も日本の誇りです。この日本の二つの「誇り」の融合により２年間冷蔵・冷凍不要で室温で保管できる本格和食ブランド「うちのや”UCHINOYA”」shop.uchinoya.comが開発されました。DSOは日本の誇りを守るために「うちのや」を世界に展開しています。
Japanese cuisine is the pride of Japan. Science and technology are also the pride of Japan. Through the fusion of these two Japanese “prides,” the authentic Japanese food brand “UCHINOYA” shop.uchinoya.com was developed, which can be stored at room temperature for two years without refrigeration or freezing.
DSO is expanding UCHINOYA worldwide to protect and preserve prides of Japan.
Hospital and Clinic Management Improvement Consulting Services
病院・クリニックの経営改善には、保険点数や周辺の病院・クリニックのマーケティング情報のほかに、実際の「医学」の観点からの考察と経営のCAPAが、全作業の80%を占めるといわれています。本Taskは大学病院の経営状態の大幅な改善を起案から実行まで成功裏に終え、自身のクリニックにおいても大いに成果を上げました元医学部教授がリードします。
現在は、大・小規模の病院およびクリニックを対象に、診療日の改善、診療時間の変更、スタッフ管理システムについてコンサルテーションを実施しています。大幅な改善が認められ、ご好評をいただいております。
Improving hospital and clinic management requires not only reimbursement and market analysis, but also medical expertise and management CAPA.
Our consulting is led by a former medical school professor who successfully improved the financial performance of a university hospital and achieved strong results at his own clinic. We currently support hospitals and clinics in optimizing consultation days and hours, as well as staff management systems, with significant improvements in performance.
各Taskへのご意見・ご質問は、お問い合わせフォームからお送りください。
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