Documentation Review Services

Whether its submission to a 3rd party service or regulatory agency or maintaining internal data, this service includes a review of the business needs and follow ups with site management to ensure compliant progress.

SOPs, forms, SSOPs, work instructions or other documents created and tailor made for your business. Includes the initial consultation and any additional reviews necessary.

Review of existing documentation or processes for improvement or correction. Includes initial consultation and progress reviews with site leadership.

Basic cGMP Documentation that will meet all minimum requirements for the regulatory compliance applicable to facility. This service includes unlimited video/ audio consultations and completed compliance packet PDF.

Comprehensive cGMP and Quality Management Documentation that is tailored to the sites individual processes for managing GMP requirements and Quality Management Needs. Documentation will meet all minimum requirements for rgulatory requirements applicable to facility, as well as detail how these requirements are met. Includes a total of 10 process SOPs for manufacturing, extracting, processing, refining activities etc as desired by the site. This service includes unlimited video/ audio consultations, completed compliance packet and 4 onsite visits.

Once the Quality system has been established, existing clients can request an annual review of documentation against current GMPs for preferred CFR.