The global pharmaceutical industry is under pressure to reduce drug development cycle time and to meet increasingly tight regulatory compliance requirements in the US, Europe, and developing markets.

We provide comprehensive end-to-end solution for client’s Pharmacogenomics, Pharmacovigilance, Bio Informatics and laboratory informatics (LIMS) requirements. Leveraging almost 10 years of consulting experience in the Life Sciences industry, we provide customized technology and services solutions. Working as a strategic business partner, we enable clients to revolutionize their Life Sciences function.

Our team of experts includes seasoned Validation Engineers, Technical Writers, pharmacists, Lab Techncians and healthcare specialists. We work closely with regulatory authorities across the world in the drug safety area. We are committed to optimize spend and staffing on quality and safety activities through continuous improvement-oriented service delivery model.

Our teams are well qualified in industry best practices for validation, qualification, compliance assessments, and vendor audits that cover systems and processes in all your regulated areas.

 
VALIDATION SERVICES
TECHNICAL EXPERTISE
   
COMPLIANCE STANDARDS
CLINICAL AND LABORATORY SYSTEMS
 
 
Computer Systems Validation

Computer System Validation (CSV) in regulated operations provides confirmation by examination and provision of objective evidence.

Validation for Vaccine Manufacturers An Introduction

This guidance document has been prepared to aid vaccine manufacturers in the preparation and performance of the validation studies required by GMP.

 
Cleaning Validation

Download Pdf

Validation Summary Report

Download Pdf

21 CFR Part 11

Download Pdf

21 CFR Part 50

Download Pdf

21 CFR Part 56

Download Pdf

21 CFR Part 58

Download Pdf

21 CFR Part 210

Download Pdf

21 CFR Part 211

Download Pdf