Sprash Pharma Consultancy aims to be competitive and unique by undertaking more challenging assignments with time bound targets and goals to achieve. It is perhaps routed
from the rich and multilevel experience gained by the promoter by working in various reputed Pharma companies.
Sprash Pharma Consultancy serves small and medium enterprises as well as large pharmaceutical organizations who are involved in the manufacturing of:
* Intermediates & Active Pharmaceutical Ingredients.
* Packing Materials.
* Medical Devices.
* Vendor Audits/ Vendor Development.
* Formulation Dosage Forms (Solid, Liquid, Semisolid, Injectables (SVP/LVP), Ointments, Creams, Aerosol etc.
* Public Testing Laboratories.
* Formulations (both sterile & non-sterile).
* Homeopathic / Ayurvedic Formulation.
* Food Products.
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.
* Documentation Specific to Industry.
* Answer all queries from Regulatory Authorities.
* 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