进军全球最大的美国市场？美国本土团队助您一臂之力！

• 支持并整合多学科评估，这些评估对于表征新药物分子的特性至关重要，使其能够进入临床阶段并启动首次人体（FIH）试验。
• 评估包括药理学（安全性和有效性）、毒理学、药代动力学以及生产工艺CMC属性。
• 利用汇集的专业知识来设计非临床计划，以支持候选药物的预期临床适应症和开发路径。

• 我们在开发小分子和大分子产品以及医疗器械的全球注册申报方面拥有数十年的丰富经验。
• 制定全面的监管策略，管理与监管机构的互动，并为临床、上市和批准后申报准备文件。
• 提供项目管理支持，并对接外包研究机构（CRO）和供应商。
  
• 与非临床、临床、CMC以及质量/合规团队无缝协作，应对全球监管和质量问题。

• 药物“可开发性”评估及候选化合物的优化
• 分析方法的开发
• 关键临床研究和商业化生产的药物开发策略
• 商业化原料药合成、制剂和工艺开发
• 为NDA（新药申请）、BLA（生物制品许可申请）、MAA（上市许可申请）及其他全球申报提供CMC信息
• 生命周期管理策略：成本优化，支持新适应症，新剂型和新配方的开发

• 代表产品申报方提供全面的GXP质量保证服务
• 主导或支持现场或远程GXP审计，包括监管检查准备、监管行动响应及整改活动
• 药品质量体系（PQS）策略、设计与实施，结合ICH Q8、Q9和Q10的要求，纳入质量风险管理和知识管理等
• GXP文件开发及审核，如程序、方案、报告、分析方法、质量标准、标准操作程序（SOP）、批记录等
• 监管行动响应及整改支持，如FDA483表格、警告信、同意令及其类似文件

• 处于上市前或早期开发阶段的客户，希望建立其临床或商业供应链，以确保无缝供应且无中断。
• 已经进入商业化的客户，旨在优化其供应链以提高吞吐量、缩短交货时间、增加库存并降低成本。
• 由于产品组合、产量、出口市场等方面的预期变化，为供应链预测重大变化做准备的客户。

• ⼈员扩充：通过具备特定技能的专家，增强内部数字创新团队的能力。
  

• 对标⾏业最佳数字能⼒——识别差距与机会。

• 审查现有数字战略，并促进制定适合目标的方法。

• 工作流程重塑与⾰新，以充分利用数字能力。

• 定制咨询服务，解读行业挑战并将其转化为需求和IT产品或平台功能。

• 儿科化合物策略（例如，儿科目标产品概况）

• 临床前差距评估（例如，是否需要额外的幼年毒理学研究）

• 监管策略，包括美国和欧盟儿科研究计划

• CMC策略（例如，选择适合年龄的剂型和配方开发，给药和剂量装置和掩味等）

• 临床策略（例如，适应症、研究类型和顺序、定义年龄组）

• 临床药理学策略（例如，剂量选择、建模和外推）

• 定制发展战略，以符合企业⽬标

• 技术⽀持尽职调查（买方或卖方）

• 能力建设提⾼价值，为管理决策和谈判策略提供依据

• 谈判策略和交易执⾏，适用于多种类型的企业交易（许可/合作/并购等）

• 联盟管理，以⽀持签署合作伙伴关系的持续义务

• Support and integrate multidisciplinary scientific evaluations essential for characterizing a new molecular entity’s properties, enabling progression into the clinic and initiation of first in-human (FIH) trials.
• These evaluations encompass pharmacology for safety and e icacy, toxicology, pharmacokinetics, and the CMC attributes that characterize the manufacturing processes.

• We leverage our collective expertise to design nonclinical plans that support the drug candidate’s intended clinical indication and development pathway.

• We have decades of extensive experience in developing global regulatory applications for small and large molecule product modalities including medical devices.
• We develop comprehensive regulatory strategies, manages agency interactions, and prepares documentation for investigational, commercial, and post-approval applications.
• Project management support is o ered, and we provide a ‘single point of contact’ interface with publishing vendors and CRO’s.

• We collaborate seamlessly with Nonclinical, Clinical, CMC, and Quality/Compliance teams to address global regulatory and quality issues.

CHEMISTRY, MANUFACTURING & CONTROLS (CMC):supporting drug substance, drug product and analytical disciplines:

• Pharmaceutical “developability” assessment and optimization of lead compounds
• Analytical methods development.
• Pharmaceutical development strategy for pivotal clinical studies and commercial manufacturing.
• Commercial API synthesis, formulation, and process development
• CMC information for NDA, BLA, and MAA submissions, and other global submissions

• Strategies for life-cycle management: cost optimizations; supporting new indications, new dosage forms and formulations.

• Full service GXP Quality Assurance on behalf of Product Sponsors
• Lead and/or support GXP Auditing (onsite or remote) including regulatory inspection readiness, and regulatory action response and remediation activities
• Pharmaceutical Quality System (PQS) strategy, design & implementation, incorporating Quality Risk Management, Knowledge Management, etc. as per ICH Q8, Q9 and Q10
• GXP documentation development and/or review (e.g., procedures, protocols, reports, analytical methods, specifications, SOP’s, batch records, etc.)

• Regulatory action response and remediation support (e.g., FDA 483’s, Warning Letters, Consent Decree, and equivalent)

• Organizations in either pre-launch or early stages of development, seeking to establish their clinical or commercial supply chains to guarantee seamless supply w/o disruption.
• Organizations who are already in commercialization, aiming to optimize their supply chain to increase throughput, reduce lead times, bolster inventories and reduce costs.

• Organizations who are preparing for significant variation in their supply chain forecasts due to anticipated changes in their product portfolio, volumes, export markets, etc.

• Staff Augmentation: Enhancing internal digital intervention team capabilities through contracted subject matter experts who provide specific skill sets
• Benchmark digital capabilities vs. industry best-in-class – highlight gaps & opportunities.
• Review existing digital strategies and facilitate creation of fit-for-purpose approach(es).
• Work-flow reinvention and disruption to exploit digital capabilities.

• Bespoke advisory services to interpret industry challenges and translate into requirements and IT products or platform functionality.

• Pediatric compound strategy (e.g., pediatric target product profile)
• Preclinical gap assessment (e.g., need for additional juvenile tox studies)
• Regulatory strategy, incl. Pediatric Study Plans (US) & Paediatric Investigational Plans (EU)
• CMC strategy (e.g., selection of age-appropriate dosage forms and formulation development; administration and dosing devices; taste masking and acceptability)
• Clinical strategy (e.g., indications, type and order of studies, defining age-groups)

• Clinical Pharmacology strategy (e.g., for dose selection, modeling and extrapolations)

• Tailored development strategies to align with corporate goals
• Technical expertise to support due diligence (buy side or sell side)
• Functional capabilities to build valuations to inform management decisions and negotiation strategies
• Negotiation strategies and deal execution for any type of corporate transaction (license/collaboration/M&A/etc.)

• Alliance management to support ongoing obligations from signed partnership