Vaatsalya Clinical is an independent Auditing and Consulting firm for Clinical trials based in Bangalore ,India.

1. AUDITING AND CONSULTING SERVICES
FOR CLINICAL TRIALS
Vaatsalya Clinical is an independent auditing and consulting firm based in
Bangalore, INDIA.
We provide full range of GCP, GLP, quality assurance audits on a global basis
and have a wide and varied range of clients, both domestic and international
clients who are conducting trials or are planning to conduct trials in INDIA
Our team provides a comprehensive range of quality assurance services,
including auditing, consulting, validation and training to pharmaceutical,
biotechnology, medical devices, and healthcare industries for.
Vaatsalya Clinical, #A003, Madhuban, Hosur Road, Adugodi, Bangalore, India 560030.
Tel / Fax : +91 080 4173 0760. http://www.vaatsalyaclinical.com

2. AUDITING AND CONSULTING SERVICES
FOR CLINICAL TRIALS
Vaatsalya Clinical Team is led by Prashanth Babu, Principal consultant who has
hands on experience in clinical field, bio analytical field and as a validation
expert. He has a Masters Degree in Pharmaceutical Sciences and is an ISO
certified lead auditor and a member of the British Association of Research Quality
Assurance.
In his career spanning 10 years, he was exposed to international audits like
USFDA, ANVISA, AFFSAPS, MHRA and domestic DCGI Inspectors. He was also
involved in Due diligence for a UK based sponsor in selecting a CRO in India.
Vaatsalya Clinical employs a team of highly experienced and dedicated
professionals with a wide range of skills necessary for the diversity of quality
assurance activities. All team members have been trained and employed by many
of the world’s premier pharmaceutical companies and contract research
organisations.
Vaatsalya Clinical, #A003, Madhuban, Hosur Road, Adugodi, Bangalore, India 560030.
Tel / Fax : +91 080 4173 0760. http://www.vaatsalyaclinical.com

3. AUDITING AND CONSULTING SERVICES
FOR CLINICAL TRIALS
AUDITING SERVICES
GCP AUDITS GLP AUDITS
DUE DILIGENCE AUDITS PHARMACOVIGILANCE AUDITS
SYSTEMS REVIEW/AUDITS CSV AUDITS
ARCHIVING AUDITS 21 CFR Part 11 Audits
In addition to auditing services, we are also working with international companies
(Sponsors) in identifying and conducting due diligence on Indian CRO’s (early stage
and established).
For the domestic clients, we are the leaders in providing support services in the
areas of systems development, documentation, consulting, liaisoning and audits.
Vaatsalya Clinical, #A003, Madhuban, Hosur Road, Adugodi, Bangalore, India 560030.
Tel / Fax : +91 080 4173 0760. http://www.vaatsalyaclinical.com

4. AUDITING AND CONSULTING SERVICES
FOR CLINICAL TRIALS
CONSULTING SERVICES
We can develop and deliver a complete auditing solution for you by implementing our
Outsourced Quality Assurance Program (OQAP). OQAP allows you to maintain quality at
your site, leveraging our quality assurance team and systems, reducing your total cost.
We focus on:
GAP ANALYSIS QUALITY MANAGEMENT CONSULTANCY
SOP WRITING DUE DILIGENCE EXERCISES
SYSTEMS AUDITS GUIDANCE WITH REGULATORY STRATEGY
REGULATORY COMPLIANCE VALIDATIONS
We work with a variety of clients in bringing in expertise on a “need-basis”. We have
worked with early stage CRO’s in building up their systems and teams. We have also
worked with large established CRO’s in reviewing and assisting in documentation
development.
Vaatsalya Clinical, #A003, Madhuban, Hosur Road, Adugodi, Bangalore, India 560030.
Tel / Fax : +91 080 4173 0760. http://www.vaatsalyaclinical.com

5. AUDITING AND CONSULTING SERVICES
FOR CLINICAL TRIALS
CUSTOMISED TRAINING PROGRAMS
Vaatsalya Clinical can provide customised training courses to meet client’s specific
needs in the areas of:
GOOD CLINICAL PRACTICE (GCP) GOOD LABORATORY PRACTICE (GLP)
CLINICAL QUALITY ASSURANCE CLINICAL TRIAL REGULATIONS (US, INDIA, EU)
DATA MANAGEMENT and CFR VALIDATION
The training courses combine lectures with workshops to ensure that theoretical
information can be applied in practice. Course manuals are provided as reference
material, and all delegates receive a Certificate of Attendance.
Vaatsalya Clinical, #A003, Madhuban, Hosur Road, Adugodi, Bangalore, India 560030.
Tel / Fax : +91 080 4173 0760. http://www.vaatsalyaclinical.com

6. AUDITING AND CONSULTING SERVICES
FOR CLINICAL TRIALS
RECENT ENGAGEMENTS:
US based Pharmaceutical Companies:
Audits and Monitoring Visits for BA/BE.
UK based Sponsor:
Data Management Audits
Computer System Validation
Contact us at
prashanth@vaatsalyaclinical.com
US based Sponsor:
Facility Audits http://www.vaatsalyaclinical.com
Vaatsalya Clinical, #A003, Madhuban, Hosur Road, Adugodi, Bangalore, India 560030.
Tel / Fax : +91 080 4173 0760. http://www.vaatsalyaclinical.com