Sprash Pharma Consultancy targets serving prospective small & medium Pharma industries who aspire to upgrade their quality and documentation system conforming to both Local & International Regulatory standards and to get accreditation from USFDA/EDQM/MHRA/TGA/ANVISA/PMDA/ISO 9000 within much economic budget under one roof.
SPRASH strongly believes to work within the available resources in any organization and shall involve from the basic level and to bring to the required standards in specified area and industry. Also, provide practical recommendations & advice on the implementation of Systems, Policies, SOPs, and Formats.
Contact us and we will make sure your SOPs are the Right Fit for your Site, Lab, or Facility. Sprash Pharma Consultancy have the necessary wherewithal to provide all the services that are required to maintain a pharmaceutical industry in a perpetually compliant state by providing all the services that are required such as:
* Preparation of DMFs/ANDA in CTD Formats.
* Preparation & Submission of Dossiers to Regulatory Bodies.
* Training & Evaluation * Auditing.
* Validations.
* Documentation Specific to Industry.
* Answer all queries from Regulatory Authorities.

Competencies shall include

* Facility / Lab design (Regulatory Standards)
* Laboratory Setup & Good Laboratory Practices (GLP)
* Facility Upgradation / Lab
* Facility Readiness for Regulatory Audits
* Facility GAP Analysis
* Auditing (Second & Third Party)
* Training & Evaluation (Personnel & GMP)

* Document Preparation – Validation Master Plan / Site Master File / Quality Manual / Policy
* Total Quality Management System
* Analytical Method Validation / Development
* Product Development /Process Validation
* Preparation of DMF/ANDA
* Regulatory Documentation/ Dossier Preparation
* Water system Validation
* Vendor Evaluation / Development
* Cleaning Validation
* HVAC Validation
* Customer Interaction and Trouble shooting
* System / Equipments Qualification