OUR ACHIEVEMENTS

Your Experts In Cell and Gene Therapy

Your Experts In Cell and Gene Therapy

Our achievements reflect our commitment to advancing groundbreaking solutions and delivering impactful results for our clients.

Technical Operations

Excellence in Technical Operations

Process Development and Manufacturing
Quality Systems
Regulatory Affairs
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Preclinical Development

Cutting-Edge Science Translated for Success

Proof-of-Concept Studies
IND-Enabling Studies
Technical Writing
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Business Operations

Business Success Through Creative and Operational Excellence

Non-Dilutive Grants/Contracts
Business Strategy/Planning
Business Development and Diligence
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CMC

We provide consulting support in the following areas:

  • Process Development & Scale-up
  • Analytical Method Development and Qualification
  • CDMO Selection and Oversight
  • Technology transfer and GMP manufacturing
  • Comparability Studies

Quality Systems

We provide the following services:

  • Establish Quality Systems
  • Develop and implement systems for GLP, GMP and GCP document management system
  • Audits: Internal and External (including Vendor) audits
  • Write SOPs and other procedural/process controlled documents
  • Provide Quality Control support

Regulatory Affairs

We provide the following services:

  • Establish Quality Systems
  • Develop and implement systems for GLP, GMP and GCP document management system
  • Audits: Internal and External (including Vendor) audits
  • Write SOPs and other procedural/process controlled documents
  • Provide Quality Control support

Proof-of-Concept Studies

We provide consulting support in the following areas:

  • Design and execution of Proof-of-concept studies
  • Animal models including human xenograft and mouse tumor models
  • In vitro and in vivo gene delivery screening platforms

IND-Enabling Studies

We provide the following services:

  • Strategic planning for IND readiness
  • Design of IND-enabling pharmacology, toxicology, persistence and tumorigenicity studies
  • Support selection of CRO for preclinical studies
  • Support implementation of GLP compliant systems

Technical Writing

We provide the following services:

  • Write study proposals and reports
  • Write SOPs and controlled documents to conduct GLP studies
  • Write pre-clinical sections of regulatory  submissions
  • Review/QC reports for IND submissions for accuracy and completeness

Non-Dilutive Grants/Contracts

We provide services in the following areas:

  • Procurement of non-dilutive government contracts/grants
  • Writing of non-dilutive grants

Business Strategy/Planning

We provide the following services:

  • Evaluate market opportunity, competitive landscape and time to market for selection and prioritization of programs
  • Development of a comprehensive product development plan and budget

Business Development and Diligence

We provide the following services:

  • In-licensing and out-licensing of compounds for therapeutic development
  • Partnering and investor due diligence
  • Message positioning and development of corporate ‘pitch’ for investors