Standard Operating Procedures and Regulatory Writing

• establishes the standard of quality;
• ensures all team members accomplish the same task by the same method;
• provides an aid for training; and
• assures compliance with FDA regulations, ICH guidelines and OECD.

SOP Services

Polaris can review your existing SOPs to determine their compliance with current regulations and guidelines, recommending revisions if necessary.

We can also draft new SOPs by developing process flows for your activities and tasks.

Polaris can create customized training courses for your existing SOPs and any SOPs we write for you. Developed for web-based or classroom delivery, our SOP training will educate your staff on your company’s procedures.

Get the tools you'll need to write SOP's with our Handbook of SOP's

Polaris can assist you with:

• Protocol review, revision, drafting for:
  • Packaging and labeling of Clinical Trial Materials
  • Equipment validation (IQ/OQ/PQ)
  • Cleaning and process
  • Methods validation protocols
  • Stability Programs
• Review, revision and drafting of:
  • Quality Manuals with associated SOPs and corresponding forms and templates
  • Investigator Brochures and updates
  • SAE narratives
  • CMC sections for INDs and NDAs
  • Clinical and non-clinical study reports
  • Annual product reports
• Serving as compliance advisors for internal staff

All FDA regulations, whether for drugs, dietary supplements, medical devices, or biologics, require that you have and follow standard operating procedures. Whether your work involves clinical trials or marketed products, Polaris will assist in reviewing your existing SOPs or writing new ones for you.

By calling Polaris  today, you can return to your area of expertise, and let our expertise in SOP reviewing, writing, and training reduce your concerns about non-compliance issues.