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!
Call Us
(781) 916-CBTG (2284)