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【iV Angel】Meadowfoam Angel Masque

Angelic Youth Renewal Ampoule

Rejuvenating Angelic Cream

Luminescent Angelic Elixir

PROTOCOL DESIGN

Chemistry, Manufacturing and Controls (CMC)

Pharmacodynamics (PD), Pharmacokinetics (PK), and Toxicokinetics (TK)

We can help streamline the process with:

PK Sample Analysis
Rapid PK Screening
ELISA Assays
Analysis of Optimal Dosing Regimen

Laboratory Solutions

Biostatistics

Investigator payments/Contract management

Patient Centered Services

Site Support/Startup

A clinical site requires a surprising amount of support that is not immediately evident. Its infrastructure needs to be documented to the satisfaction of regulatory authorities, and encompasses a wide array of subtopics, including equipment and information storage, system controls, blinding, data transparency, data sharing, record keeping, physical and digital security, technological capabilities, hiring processes, conflicts of interest, operational infrastructure, maintenance, among others.
Additional requirements include safety reporting, preventive and corrective actions, participant engagement, risk/benefit communication, informed consent, participant welfare, IRB approval.

Customized Solutions

Regulatory Support

Screening & Profiling Assays

Pharmacology & Toxicology Studies

Laboratory Solutions

Cell Sourcing

IND Submission

Eliminate regulatory pitfalls
Keep development on track
Ensure appropriate strategy at each step
Structured data management

Fact-based decisions to improve probability of success and regulatory approval
Risk analysis and mitigation, both regulatory and operational
Highly transparent workflow and communication

Regulatory Strategy Consulting

Regulatory strategy consulting is essential for navigating the intricate regulatory landscape of the pharmaceutical and biotech industries. Expert consultants provide guidance on developing tailored strategies to expedite product approval processes, ensure compliance with regulations, and optimize market access.
From early-stage planning to post-market support, regulatory strategy consulting ensures companies meet regulatory requirements efficiently, enabling them to bring innovative therapies to market swiftly and effectively.

Asset Development

All but the largest biotech companies face considerable drug development challenges, as they often need to keep teams small and agile enough to maintain a competitive and innovative edge. Further, they are faced with resource constraints and will likely encounter a problem that cannot be addressed with in-house capabilities. Worse, they have a lack of trustworthy partners to confide in their intellectual properties (IP).

Through YC Biotech’s end-to-end solutions, we can simultaneously ameliorate all these concerns and ensure a smooth transition from preclinical to IND.

化學、製造和控制（CMC）

藥效學 (PD)、藥物動力學 (PK) 和藥物動力學 (TK)

PK樣本分析
快速PK篩選
ELISA 測試
最佳給藥方案分析

臨床試驗的財務規劃與合約管理

在新藥開發和生物科技領域，制定有效的策略至關重要。

送審IND（Investigational New Drug）

釐清法規內容
保持開發進度維持在正軌
確保在每一步都採取適當的策略
建立結構化的數據管理

基於事實的決策，以提高成功機率和監管批准的可能性。
監管和營運方面的風險分析和解決方案。
高度透明的工作流程和溝通

對於許多新創的生物科技公司而言，藥物開發的道路充滿了挑戰。他們需要在保持團隊的靈活和創新的同時，又需要面對資源上的許多限制。這樣的環境下，他們可能難以內部解決所有問題，也缺乏可信賴的合作夥伴來保護知識產權（IP）。
昱君生技作為一家專業的CRO公司，致力於提供全方位一站式解決方案，協助生物科技公司克服種種挑戰。我們了解到，從臨床前研究到IND申請的每個階段都需要專業的支持和協助。因此，我們提供了全方位的服務，以確保客戶可以順利通過每個研發里程碑。
透過我們的服務，生物科技公司可以專注在核心業務，放心地將藥物開發的其他方面交給昱君生技。我們不僅提供專業的技術支持，還確保客戶的知識產權得到充分保護。使生物科技公司可以在競爭激烈的市場中保持領先地位，實現創新並取得成功。

昱捷與昱君攜手，共啟 G-BeBite® 櫻普倫人工牙根植體系統人體試驗

🔸Contains fully absorbable nanomolecular exosomes (stem cell grade)

🔸Provides deep tissue regeneration and revitalization

🔸Incorporates a curated assortment of tripeptides and tetrapeptides to effectively combat wrinkles, dry skin, and inflammation

🔸Utilizes high molecular weight hyaluronic acid for prolonged hydration

🔸Enriched with hydrolyzed marine collagen to enhance skin firmness and elasticity

🔸Completely absorbable stem cell grade nanomolecular exosomes

🔸An elixir for rapid restoration of skin

🔸A soothing, moisture retaining, anti-aging concoction

🔸Contains fully absorbable nanomolecular exosomes (stem cell grade)

🔸Provides deep tissue regeneration and revitalization

🔸Incorporates a curated assortment of tripeptide & tetrapeptides to effectively combat wrinkling, dry skin and inflammation

The complexity and demands of protocols have increased in recent years.

That complexity is putting a burden on patients and investigators alike and can heavily impact patient enrollment rates.

Yet amending protocols mid-stream will noticeably increase the time and cost of the development program with no guarantee of outcome improvement.

All stages of the drug development life cycle, after drug discovery involve CMC.

After clinical trials the scale-up process must ensure that the larger batches of product are the same and meet the same specifications as the drug tested in the clinical trials, and after the manufacturing process is qualified, lot release and in-process testing will continue to take place.

試驗計劃的複雜性和要求近年來不斷增加，使受試者和研究人員帶來了負擔，也可能影響受試者的參與率。然而，中途修改試驗計劃將增加開發計劃的時間和成本，並不能保證結果的改善。

透過我們的專業支持，客戶可以確保其藥物開發過程順利進行，並符合相關的法規和品質標準，從而實現成功的藥物上市。

PK樣本分析

快速PK篩選

ELISA 測試

最佳給藥方案分析