Polaris Compliance Consultants, Inc.
  • Home
  • Services
    • Good Clinical Practice (GCP) Audits
    • Good Laboratory Practice (GLP) and Good Clinical Laboratory Practice (GCLP) Audits
    • Good Manufacturing practice (GMP) Audits
    • Computer System Validation (CSV)/Part 11 Audits
    • CAPA and Remediation
    • SOP Development
    • Strategic Quality Consulting
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  • About Us
    • Leadership Team
    • Why Choose Polaris
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​SOP Development

Polaris has decades of experience writing SOPs for investigative sites, sponsors, CROs, IRBs, nonclinical laboratories, manufacturing facilities, IT organizations, and technology-related vendors. We begin by looking at your existing processes to make sure they comply with current regulations and guidelines, are aligned with industry best practices, and clearly outline roles and responsibilities. From there, we can develop new SOPs, or revise your existing ones. Afterward, we can create customized training courses to educate your staff on your company’s procedures.
 
SOPs should be clear and detailed enough to allow staff members to know what is expected of them, but not so detailed that non-compliance with your own SOPs becomes an issue. Polaris SOP Writers can help you with:
  • SOP Gap Analysis
  • SOP Authoring
  • SOP Review and Revision
 
Polaris can perform SOP gap analyses and develop SOPs in the following areas:
  • GCP
  • GLP / GCLP
  • GMP
  • Part 11/ CSV
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Compliance & quality consulting for your business success

Contact Us To Begin
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Over 25 Years of Compliance and Quality Consulting for the Life Science Industry
SERVICES
Good Clinical Practice (GCP) Audits
Good Laboratory Practice (GLP)
Good Clinical Laboratory Practice (GCLP) Audits
Good Manufacturing Practice (GMP) Audits
Computer System Validation (CSV)/Part 11 Audits
CAPA and Remediation
SOP Development
Strategic Quality Consulting
ABOUT US
Leadership Team
Why Choose Polaris
Careers
In The Community

​CONTACT US


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  • Home
  • Services
    • Good Clinical Practice (GCP) Audits
    • Good Laboratory Practice (GLP) and Good Clinical Laboratory Practice (GCLP) Audits
    • Good Manufacturing practice (GMP) Audits
    • Computer System Validation (CSV)/Part 11 Audits
    • CAPA and Remediation
    • SOP Development
    • Strategic Quality Consulting
  • Resources
  • About Us
    • Leadership Team
    • Why Choose Polaris
    • Careers
    • In The Community
  • Contact