SCI•X delivers comprehensive project facilities support to align our clients' facilities and operaions with their business goals as well as all compliance standards. Our Partner, The Cerneos Group, provides a wide array of expertise in the Life Science industry. Client staff augmentation can also be arranged should that be a need.  Through this partnership, we are able to provide a full complement of facilities and product development services to assist startup and to mature biotech, biopharma and pharmaceutical companies. This strategic partnership allows us to provide regulatory,

 product development and clinical evaluation capabilities.  Together, we can help you develop and FDA compliant products at each step of development.  We help clients transition from formulation, pre-clinical development, clinical trials, regulatory filings, and product launch and post market surveillance.  Our staff and strategic partnerships bring years of design and development experience, cGMP and global compliance knowledge, and industry insights to provide state-of-the-art facilities and new product development capabilities for our clients.  Together, we are a seamless, consolidated team dedicated to the success of our clients.

Global Regulatory Services

Global Regulatory Affairs
Project Management
Concept to Commercialization

Software Services                      

Software Quality Assurance
Software Validation
Agile SW Development Guidance
Software Quality Auditing

Drug & Therapeutic Manufacturing

Formulation & Scale Up
Aseptic Fill & Finish
Operations & Support
Biosimilars Development
Bulk Drug Manufacturing

Drug & Therapeutic Manufacturing

Formulation & Scale Up
Aseptic Fill & Finish
Operations & Support
Biosimilars Development
Bulk Drug Manufacturing

Laboratory Technical Services

Lab/Facility Development & Validation
Assay Development
Infrastructure Process Development
Drug Research & Development
Program & Alliance Management
Target Discovery Advancement
IND/Phase I Clinical Trial Preparation