Quality Assurance.
Validation.
Regulatory Submissions.

At Softworld Life Sciences, we specialize in providing our clients with end to end project support and individual consulting support. Whether you need a team of specialized consultants for an upcoming project or an individual to help your growing team, Softworld Life Sciences is here to help.

Softworld Life Sciences recruits talent in these key skill disciplines:

Biometrics

  • Biostatistics
  • SDTM / ADaM
  • CDISC/CDASH Analyst

Validation

  • Process
  • Cleaning
  • Aseptic
  • Equipment Packaging
  • Protocol Writing
  • CQV / FAT
  • CSV
  • Commission / Decommission
  • Metrology

GCP, GMP, GLP, GXP

  • Metrics
  • QMS
  • Best Practices
  • Audit / Mock – Prep
  • Process Improvement
  • 21 CFR Part 11

Regulatory

  • Submission Management
  • IND / NDA
  • Dossier Compilation
  • Compliance Remediation
  • Regulatory Strategy
  • Post approval maintenance

Quality

  • CAPA / Root Cause
  • 483 / Consent
  • Deviation
  • Process Improvement
  • SOP / Documentation
  • Batch / Deviation Review
  • Protocol Writing

Why choose Softworld Life Sciences?

Domain Expertise

Softworld Life Sciences offers national consulting support. We are experts in the Quality, Validation and Regulatory fields and have successfully completed engagements with over 200 different pharmaceutical clients.

Flexibility.

Project outsourcing. Consulting. Contract staffing. We provide resources in a manner that best matches each client’s distinct needs. That means we give our clients greater project control, less risk and a better cost structure than traditional outsourcing or staffing solutions.

Speed.

Because of the talent we have on staff and in our network, we are able technical resources faster in our core areas…typically in 24 to 48 hours.