在開始您的臨床之旅前,請先了解您的目的地/目標在哪裡—藥物開發計畫的價值

從一開始就建立智能臨床開發計畫路徑,對於明確達成產品登記所需的複雜流程十分重要。

藥物開發計畫 (DDP) 對於臨床旅程的每個環節,從預算、募資、時間表、臨床階段、研究合作夥伴、研究地點、主管機關的參與、員工招聘等,皆會發送通知。

最終,DDP 說明了產生支援上市許可證和補償的證據所需的步驟。

一個對外的 DDP 顧問團隊需要精通所有法規事務和產品開發,包括製造、毒理學和醫學寫作,並且規劃應從臨床前的開發階段開始。

規劃流程可降低不可預期的風險,包括非預期的監管法規障礙和成本,並確保藥物的開發進度符合投資者的預期,並最佳化整個臨床計畫的資源。

它還涵蓋了藥品的化學製造管制 (CMC) 品質要求、非臨床要求、所需的非臨床動物試驗以及支援產品登記的臨床試驗的類型和範圍。

除了典型的第 I、II 和 III 期試驗計畫外,DDP 還可以重點強調任何額外的要求,或支援申請時可能需要的試驗,例如特殊族群的臨床試驗或藥物相互作用試驗。

最重要的程序之一,是對市場上或目前正在開發的產品進行商業或競爭對手的分析。這會通知支援產品上市許可證所需的試驗類型和資訊。

強健牢靠的 DPP 也會識別出加快藥物核准的方法。為了加快藥物開發和獲得核准,主管機關提供了一系列的流程。這些流程包括指定用於罕見適應症的孤兒藥,對於影響危及生命的疾病的真正令人振奮的產品,有包括突破性療法和快速追蹤指定計劃在內的選項。

Services

Regulatory Strategy

Novotech Drug Development Consulting can act as your Authorized Representative to the FDA and will take on responsibility for successful interactions with the Agency. We also offer strategic and tactical planning for FDA, TGA, and EMA interactions. 

  • US Regulatory Representation (FDA - CBER, CDRH, CDER)
  • Design of Integrated Regulatory, Scientific, and Clinical Strategies for Global Product Development
  • Experts in Conducting FDA, TGA, and EMA Meetings and Filings
  • Scientific Advice
  • Risk Management and Due Diligence
  • OGTR/EPA Licenses for GMO Products
  • Institutional Biosafety Committee (IBC) Support


CMC and Product / Analytical Consulting

Novotech Drug Development Consulting offers scientific review of processes, programs, and testing, as well as design of pilot, validation, and tech transfer programs to support regulatory filings worldwide.

  • Product, Process, and Method Development and Validation Strategy
  • Technical Writing and Data Review
  • Regulatory Positioning
  • On-Site Data Management


Clinical and Nonclinical (Toxicology/Pharmacology) Consulting

We can develop Clinical Development Plans (CDP) and all clinical study documents. 

  • Medical and Clinical Program Strategy
  • Clinical Development Planning
  • Proprietary "Real Time" Audit Services

Our nonclinical services include planning and designing studies, selecting contract laboratories, and evaluating study conduct, data, and final reports.

  • Oversight for Nonclinical and Toxicity Studies
  • Design and Review GLP-Compliant Toxicology Studies in Support of Human Studies and Marketing Approval


Quality / GMP / CMC Consulting

We are experienced in development of QA systems and cGMP compliance programs. We also offer oversight of manufacturing and testing and can conduct due diligence of CMOs.

  • Experts in cGMP Compliance
  • Extensive Experience in Design and Oversight of Quality Systems
  • On-Site Mock Audits/PAIs
  • Experienced in Building QA Systems for Biotechs and Start-ups
  • Experts in Biological CMC


Electronic Submissions

We have over 15 years of experience in electronic submissions to the FDA and other regulatory authorities around the globe. We provide tailored services to meet client needs, utilizing state-of-the-art software solutions to deliver compliant e-submission documents.

  • Electronic publishing and lifecycle management services
  • Global filing capabilities to manage multi-country submissions
  • Strategic guidance to ensure a streamlined, end-to-end submission process
  • Customized training for program implementation and best practices


Accomplishments for Our Clients in the Last 5 Years:

  • Assisted or published 23+ INDs, 16 with a major role
  • Authored and submitted 6 Orphan Drug Designations and Master Files
  • Supported 3 NDAs/ANDAs and 2 BLAs
  • US Regulatory Representative or US Agent for 18 dossiers currently and 51+ in the last 5 years (INDs, pre-INDs, NDAs, BLAs, and Orphan Drug Designations)
  • Conducted 67+ FDA meetings/teleconferences or WRO
  • Complete 250+ submissions to regulatory authorities per year

DDP 主要重點包含:

基本原理

從產品開發的科學原理開始,其中包括目標適應症的簡短總結,以及開發產品的原因。這為產品開發奠定基礎。

競爭對手

對市場上或目前正在開發的類似競爭產品進行分析。這是商業分析的重要部分,但也為支援產品上市許可證所需的試驗類型和資訊提供了有用的資訊。

目標市場

產品目標可以設定要在全球各地註冊,也可以先在例如亞太地區等單一地區註冊,而美國和歐洲等其他地區可在以後的開發計畫中再行添加。

產品製造

對不同開發階段的製造品質規定進行評估。從第一期 GMP 開始,一直到上市許可證的整個過程驗證。

臨床策略

如果說需要考慮到其他族群,則可能會擴大包括第 I 期、第 II 期、第 III 期的臨床試驗策略,或者可能有機會進行壓縮的臨床開發策略。

財務

商業重要性需要時間表和成本,或者至少需要預估,如此公司才知道要籌集多少資金或需要多長時間完成試驗。

決策點

最後,在開發計畫中,納入您判斷是否值得繼續開發此試驗計畫的關鍵決策點。

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