Post on 13-Jan-2016
ACCREDITED CONSULTANTS PVT LTD. (ACPL)
ACCREDITED CONSULTANTS PVT LTD. (ACPL)
WELCOMES YOU
Your PHARMACOVIGILANCE PARTNER
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.
ACCREDITED CONSULTANTS PVT LTD. (ACPL)ACCREDITED CONSULTANTS PVT LTD. (ACPL)
www.acplgroupindia.co.in
ACPL is the leading Pharmacovigilance service provider in India.
We provide a wide range of pharmacovigilanceconsultative services to various pharmaceutical companies across the world.
ACCREDITED CONSULTANTS PVT LTD. (ACPL)ACCREDITED CONSULTANTS PVT LTD. (ACPL)
www.acplgroupindia.co.in
Our Aim & GoalAdhere the regulatory standards and maintain the compliance which helps to
ACCREDITED CONSULTANTS PVT LTD. (ACPL)ACCREDITED CONSULTANTS PVT LTD. (ACPL)
Improve Patient Care
Improve Public Health
Risk Benefit Assessment of medicine
effective communication to health
professionals & the public
www.acplgroupindia.co.in
Consulting Services that meet your needs
ACCREDITED CONSULTANTS PVT LTD. (ACPL)ACCREDITED CONSULTANTS PVT LTD. (ACPL)
www.acplgroupindia.co.in
ACPL provides a wide range of pharmacovigilance services
ACCREDITED CONSULTANTS PVT LTD. (ACPL)ACCREDITED CONSULTANTS PVT LTD. (ACPL)
Management of case reports and adverse event reportingIndividual 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
www.acplgroupindia.co.in
Aggregate/Periodic Report Writing & Submission
ACCREDITED CONSULTANTS PVT LTD. (ACPL)ACCREDITED CONSULTANTS PVT LTD. (ACPL)
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.
www.acplgroupindia.co.in
Routine safety surveillance, signal detection & Management
ACCREDITED CONSULTANTS PVT LTD. (ACPL)ACCREDITED CONSULTANTS PVT LTD. (ACPL)
Collection of ICSRs from database
Data cleaning & duplicate detection Signal interpretation (by quantitative or statistical methods)
Assessment for signalsRecommendation for action (including label update analysis and physician review)
www.acplgroupindia.co.in
Risk Management Plans (RMPs)
ACCREDITED CONSULTANTS PVT LTD. (ACPL)ACCREDITED CONSULTANTS PVT LTD. (ACPL)
Risk-benefit management and analysis: ACPL provides strategic advice and analysis to develop updates risk management plans.
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
ACCREDITED CONSULTANTS PVT LTD. (ACPL)ACCREDITED CONSULTANTS PVT LTD. (ACPL)
www.acplgroupindia.co.in
ACCREDITED CONSULTANTS PVT LTD. (ACPL)ACCREDITED CONSULTANTS PVT LTD. (ACPL)
ACCREDITED CONSULTANTS PVT. LTD.
(Email: bhatbio@gmail.com, info@acplgroupindia.co.in)(Website: acplgroupindia.co.in)
(Contact: +91 22758204, 9350040434, 9310040434, Fax: 22758994)D-29, 1ST FLOOR, ACHARYA NIKETAN, MAYUR VIHAR
PHASE-I, NEW DELHI-110091