Our Products
Created for you
Example Page:
| Created for you | Description | Price | |
|---|---|---|---|
| 1 | Certificate of Analysis | Send Data and Specifications, CoA will be generated. A logo may be added if needed. | $500 |
| 2 | SDS | Send relevant information about drug substance or drug product and a GHS-compliant SDS. | $500 |
| 3 | Specification | Drug substance, drug product, excipient, or component specification document; raw materials, in-process, and finished goods. Send requirements and official document will be generated. | $350 |
Template Organizational Document
Example Page:
| Template Organizational Document | Description | PRice | |
|---|---|---|---|
| 1 | Quality Policy | A template QP for pharma and medical device industries. | $250 |
| 2 | Quality Manual | A template QM for pharma and medical device industries; ISO 9001 and ISO 17025 possible. | $350 |
| 3 | Quality Plan | A template Quality Plan for quality initiatives. | $400 |
| 4 | Site Master File | A template SMF to describe facilities, products, and processes for an organization. | $400 |
Template SOP
Example Page:
| Template SOP | Description | Price | |
|---|---|---|---|
| 1 | SOP – Document Control | A template SOP and associated FORM to manage document systems compliant with ICH Q10, 21 CFR 211 and 21 CFR 820. | $350 |
| 2 | SOP – Record Control | A template SOP and associated FORM to manage records compliant with ICH Q10, 21 CFR 211 and 21 CFR 820. | $350 |
| 3 | SOP – Training | A template SOP and associated FORMS to manage training programs. | $350 |
| 4 | SOP – Management Review | A template SOP for the Management Review process compliant with ICH Q10, 21 CFR 211 and 21 CFR 820. | $400 |
| 5 | SOP – Risk Management | A template SOP and associated FORM to describe the process for assessing and managing risk. | $400 |
| 6 | SOP – Corrective and Preventive Actions | A template SOP and associated CAPA RECORD FORM to manage corrective and preventive actions systems compliant with ICH Q10, 21 CFR 211 and 21 CFR 820. | $350 |
| 7 | SOP – Deviations | A template SOP and associated DEV RECORD FORM to manage deviation systems compliant with ICH Q10, 21 CFR 211 and 21 CFR 820. | $350 |
| 8 | SOP – Out of Specification / Unexpected Results Investigation | A template SOP and associated OOS/OOT/IUR RECORD FORM to managed laboratory findings compliant with ICH Q10, 21 CFR 211, and 21 CFR 820. | $400 |
| 9 | SOP – Root Cause Analysis | A template SOP and associated RCA RECORD to describe the process for performing root cause analysis. | $400 |
| 10 | SOP – Complaints | A template SOP and associated COMPLAINT RECORD FORM to manage complaint systems compliant with ICH Q10, 21 CFR 211 and 21 CFR 820. | $350 |
| 11 | SOP – Good Documentation Practices | A template SOP for describing GDP for GMP and GLP. | $350 |
| 12 | SOP – Specifications | A template SOP for describing the process of creating and managing specifications. | $350 |
| 13 | SOP – Quality Agreements | A template SOP and example AGREEMENT template to manage quality agreements with contract service providers. | $500 |
| 14 | Any SOP made to order | Any quality SOP which is needed may be requested and pricing will be appropriate to the requirements. | TBD |