Key to Quality and Regulatory compliance

Source Life Science Consulting LLC helps you navigate the regulatory landscape throughout the product life cycle.

SOURCE LIFE SCIENCE CONSULTING LLC is a trusted and experienced partner who can help you identify problems and implement solutions to meet Quality compliance requirements. Our seasoned experts, many of whom have agency experience, will work with you and your staff on the shop floor and in the board room to help you proactively avoid future compliance problems.

With increasing regulatory pressures it is critical that every phase of your process is scrutinized. That’s what we do. Our consultants bring years of industry experience –we have walked in your shoes and we understand your regulatory challenges. We see the big picture, from application strategy through product approval and beyond.

An Industry Leader in Compliance Services & Quality Assurance the company provides hands-on expertise to optimize and maintain our clients’quality systems, while providing compliance services through cost-effective resources.

The SOURCE LIFE SCIENCE CONSULTING LLC offers the following value-added QA and compliance services:

  • Quality System (QS) Development, Assessment & Optimization
  • Root Cause Investigations & Corrective & Preventive Action (CAPA) Planning & Execution.
  • Training –FDA, GMP, QSR, Validation, etc.

Compliance Services:

  • Third-party GMP & GLP Compliance Auditing.
  • Mock FDA/International Regulatory Agency Inspections & PAI Readiness.
  • Due Diligence Compliance Inspections, Audits & Assistance.
  • FDA Action (483 Observations, Warning Letters, Consent Decrees) Remediation.

As a compliance company, the senior staff of quality, compliance and program/project management professionals at SOURCE LIFE SCIENCE CONSULTING takes a proven, hands-on approach to addressing our clients’specific QA and compliance situations to ensure their quality and regulatory operations are in compliance with current industry standards and FDA/international regulations. As a leader in the regulatory environment, rest assured the organisation is the compliance company of choice for the pharmaceutical, biotech and medical device industries.

The consulting company includes a powerful blend of consultants with FDA and industry experience —including leading scientific and technical experts who help ensure that recommendations are not only scientifically and technically accurate, but also actionables.