Pharmacovigilance

1. ACCREDITED CONSULTANTS PVT LTD.
(ACPL)
ACCREDITED CONSULTANTS PVT LTD.
(ACPL)
WELCOMES YOU
YOUr
PHArMACOVIGILANC
E
PArTNEr

2. www.acplgroupindia.co.in
Pharmacovigilance is concerned with identifying the
hazards associated with pharmaceutical products and
with minimizing the risk of any harm that may come to
patients.
As per new legislation, MAH should be responsible
for continuously monitoring the safety of its medicinal
products for human use.

3. www.acplgroupindia.co.in
ACPL is the leading Pharmacovigilance service
provider in India.
We provide a wide range of pharmacovigilance
consultative services to various pharmaceutical
companies across the world.

4. www.acplgroupindia.co.in
Our Aim & Goal
Adhere the regulatory standards and maintain the
compliance which helps to
Improve Patient Care
Improve Public Health
Risk Benefit Assessment of medicine
effective communication to health
professionals & the public

5. www.acplgroupindia.co.in
Consulting Services
that meet
your needs

6. www.acplgroupindia.co.in
ACPL provides a wide range of pharmacovigilance
services
Management of case reports and adverse event reporting
Individual Case Safety Report (ICSRs) Processing
Post Marketing Solicited and Spontaneous Reports‐
Clinical trial Reports.
Special Reports: Pregnancy reports etc.
Medical Device related Reports
Social media mining
Literature Reports

7. www.acplgroupindia.co.in
Aggregate/Periodic Report Writing & Submission
Aggregate & Periodic Report Writing reports
(PSURs/PBRERs/PADERs, DSURs)
Addendum reports
Bridge reports
Annual safety reports etc.
These reports are prepared in the proper format with
appropriate content and submitted to the relevant
regulatory authorities within compliant timelines.

8. www.acplgroupindia.co.in
Routine Safety Surveillance, Signal Detection & Management
Collection of ICSRs from database
Data cleaning & duplicate detection
Signal interpretation
(by quantitative or statistical methods)
Assessment for signals
Recommendation for action
(including label update analysis and physician review)

9. www.acplgroupindia.co.in
Risk Management Plans (RMPs)
Risk-benefit management and analysis:
ACPL provides strategic advice and
analysis to develop updates risk
management plans.

10. www.acplgroupindia.co.in
Why ACPL?

Our team of dedicated drug safety and educational
professionals offer our clients superior service and programs.

A compliance and client-oriented mindset to deliver quality
within time.

World class, robust and refined technical infrastructure.

Exclusively, global drug safety service provider.

Last but not the least, we provide excellent quality services at
highly competitive prices

11. www.acplgroupindia.co.in
ACCREDITED CONSULTANTS PVT. LTD. (ACPL)ACCREDITED CONSULTANTS PVT. LTD. (ACPL)
Contact Details:
Accredited Consultants Private Limited,
D-29, First Floor, Acharya Niketan,
Mayur Vihar Phase-I, Delhi-110091.
Ph: 011-22758204,
(M) +91-9310040434, +91-9266665201
Fax: 011-22758994
Email:
info@acplgroupindia.com
info@acplgroupindia.co.in
prasad_bhat@hotmail.com
Websites:
www.apclgroupindia.com
www.apclgroupindia.co.in