(781) 916-2284 [email protected]

Life Sciences

Supporting Mission-critical Projects and Initiatives

Where We Help

The ClearBridge Life Sciences practice helps support mission-critical projects and initiatives by providing high-end consultants who are well-versed in cutting-edge technologies and innovations.

Nowhere are such needs more crucial than in the Life Sciences industry, where success translates to better care, more advanced treatments, and life-changing therapies.

Our commitment to staying on the forefront of these technologies & sciences, and our understanding of FDA compliance / GMP processes & procedures, along with our proprietary delivery methodology, uniquely positions us to support and provide solutions across the Life Sciences industry.

Whether it’s support for development, clinical & lab, quality & validity, safety, remediation, or regulatory & compliance, ClearBridge can help. Contact us to learn more.

 

Expertise

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

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

CAPA & Remediation

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

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.)

We're Here To Help!

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Call Us

(781) 916-CBTG (2284)