Lindville Bio
Lindville Bio
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  • Client Resources
    • QC: Clinical Grade iPSC
    • Glossary of ATMP Terms
    • EMA stem cell reflections
    • iPSC Market Report
    • hESC Practical Handbook
    • EMA Reg Charts & Lists
    • Comparability
    • Global HLA data
    • iPSC Company Database
    • GMP Simulation Suite
  • iPSC patient registry
  • Contact Us
  • Using the Registry
  • Registry Usability
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    • Home
    • Our Services
    • Client Resources
      • QC: Clinical Grade iPSC
      • Glossary of ATMP Terms
      • EMA stem cell reflections
      • iPSC Market Report
      • hESC Practical Handbook
      • EMA Reg Charts & Lists
      • Comparability
      • Global HLA data
      • iPSC Company Database
      • GMP Simulation Suite
    • iPSC patient registry
    • Contact Us
    • Using the Registry
    • Registry Usability
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  • Home
  • Our Services
  • Client Resources
    • QC: Clinical Grade iPSC
    • Glossary of ATMP Terms
    • EMA stem cell reflections
    • iPSC Market Report
    • hESC Practical Handbook
    • EMA Reg Charts & Lists
    • Comparability
    • Global HLA data
    • iPSC Company Database
    • GMP Simulation Suite
  • iPSC patient registry
  • Contact Us
  • Using the Registry
  • Registry Usability

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Our Services

 At Lindville Bio,  we help clients develop a clear roadmap for efficient 

iPSC/hESC therapy translation. Our team offers strategic advice on the following areas: 

Process Development

iPSC/hESC Line Assessment, Identification & Procurement

Donor Material & Informed Consent

 We provide strategic advice on process development, considering the indication and shape of the final therapeutic product from the beginning, ensuring quality, scalability, and flexibility

Donor Material & Informed Consent

iPSC/hESC Line Assessment, Identification & Procurement

Donor Material & Informed Consent

 We provide guidance on the identification and selection of suitable donor material for therapeutic development and offer donor consent services

iPSC/hESC Line Assessment, Identification & Procurement

iPSC/hESC Line Assessment, Identification & Procurement

iPSC/hESC Line Assessment, Identification & Procurement

 Our team offers guidance on sourcing suitable lines for the desired indication and population, identifying lines under clinical and commercial licenses 

Regulatory Affairs & Approval

Market Analysis and Company Positioning

iPSC/hESC Line Assessment, Identification & Procurement

 Our regulatory affairs and approval services help clients navigate the regulatory landscape and meet the requirements of different jurisdictions, preparing GMP documentation for regulators 

Licensing & Freedom to Operate

Market Analysis and Company Positioning

Market Analysis and Company Positioning

 We provide intellectual property review and licensing services for research, clinical and commercial purposes, helping clients to gain the freedom to operate and understand how that affects the translation strategy


Market Analysis and Company Positioning

Market Analysis and Company Positioning

Market Analysis and Company Positioning

 Our team provides global resource and market analysis services, helping clients understand the demand for iPSC/hESC therapies, investment trends, and selecting the best market and indication for their product 


Engraftment & Immunomodulation

We offer guidance on human leukocyte antigens (HLA) matching and immunomodulation for allogeneic therapies


Usability & Clinical Impact

We help to understand the consequences of the final therapeutic format from the beginning, and provides guidance on  the level of expertise required to administer the therapeutic product and how it contributes to the clinical impact 


Final Therapeutic Product Logistics

Tailored Educational Material Generation

We provide guidance on Supply Chain Assessment, 

Supplier Assessment & Redundancy Integration and 

Critical Logistic Attributes

Tailored Educational Material Generation

Tailored Educational Material Generation

Tailored Educational Material Generation

 We generate tailored educational materials for technical personnel to teach facility operations, regulatory obligations, and the rationale behind compliance 

Assistance with Investor Due Diligence

Tailored Educational Material Generation

Assistance with Investor Due Diligence

We provide investors with in-depth evaluations of companies' scientific, clinical, manufacturing, business, and promotion strategies to inform investment decisions 

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