Documentation Supports

We help the firms in designing their documentation system to meet international standards of US FDA, WHO, EU, PICS, TGA, ICH Q7, MHRA, PMDA,EDQM.MCC, The documents shall include QMS, Batch documentation, Validation, Recording forms and formats and SOPs and all relevant /associated GMP documentation.
We review the firms SOPs for performance and compliance. We provide the firm’s prototypes (templates) of few SOPs based on which the firms are expected to prepare and expand their SOPs.
We also assist the firm in preparing master GMP documentation where required and review the documents for their completeness and compliance.