(781) 916-2284 sales@clearbridgetech.com

Life Sciences

About

Where We Help

ClearBridge has operated on the frontlines of cutting-edge technologies and innovations from our inception, supporting mission critical projects and initiatives to fit our clients’ needs and drive progress forward. Nowhere are such needs more crucial than in the Life Sciences industry, where success translates to better care, more advanced treatments and medications, pandemic-ending vaccines, life-changing/saving therapies & devices, etc. to increase quality of life to people on a global scale and save countless lives.

Our commitment to staying on the forefront of these technologies & sciences, and our understanding of FDA compliance/GMP processes & procedures, uniquely positions us to support companies in the Life Sciences industry. Additionally, our internal process, developed over the course of 15+ years, allows us to be extremely effective in providing our clients with the right resources, quickly and effectively. For these reasons, we have earned a stellar record for our efficacy, our values, and our uncommon commitment to our clients.

We offer support in a number of areas:

Pharmaceutical/Medical Device Development

Analytical Development

Clinical & Lab Support

Project Management

Quality Assurance & Validation

Technology Transfers

CAPA & Remediation Support

Regulatory Affairs/FDA Compliance

Advanced Computer/Software Support

Post-Market Surveillance & MDR’s

Our Expertise

Get in touch with the Subject Matter Experts from our Life Sciences Practice to see where we might help your company grow.

 

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Life Sciences

A Closer Look…

QC/R&D/Development

  • New Product Development
  • Chemical/Pharmaceutical Development
  • Analytical Development
  • QC/Microbiology Lab Support

Clinical & Lab Support

  • Clinical Trial Management, Clinical Research Coordinators
  • LIMS, Lab Technicians

CAPA & Remediation

  • Corrective and Preventative Action Support including Internal/3rd Party Audits
  • Remediation Project Coordination/Planning
  • FDA Action Response (483’s, Warning Letters, etc.)

Quality Assurance/Validation

  • Quality Management Systems
  • Quality Engineering
  • Quality/GMP Audits
  • Change Control
  • Writing/Executing Protocols and SOP’s
  • Validation/Qualification/Commissioning/Calibration
    • Validation: Process, Equipment, Computer Systems/Software,
    • IQ/OQ/PQ 

Regulatory Affairs/FDA Compliance/Submissions

  • NDA/ANDA, IND, BLA, EUA, DMF/BMF Submissions
  • Packaging/Advertising Compliance
  • Manufacturing Site Registration
  • Regulatory Planning
  • Foreign Submissions (Canada, EU, China, etc.)