1. ACCREDITED CONSULTANTS PVT LTD. (ACPL) WELCOMES YOU Your PHARMACOVIGILANCE 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. 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)

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. 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. ACCREDITED CONSULTANTS PVT LTD. (ACPL)

4. www.acplgroupindia.co.in Our Aim & Goal Adhere the regulatory standards and maintain the compliance which helps to Our Aim & Goal Adhere the regulatory standards and maintain the compliance which helps to ACCREDITED CONSULTANTS PVT LTD. (ACPL)  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 Consulting Services that meet your needs ACCREDITED CONSULTANTS PVT LTD. (ACPL)

6. www.acplgroupindia.co.in ACPL provides a wide range of pharmacovigilance services ACCREDITED CONSULTANTS PVT LTD. (ACPL) 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 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.

8. www.acplgroupindia.co.in Routine safety surveillance, signal detection & Management Routine safety surveillance, signal detection & Management ACCREDITED CONSULTANTS PVT LTD. (ACPL)  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) ACCREDITED CONSULTANTS PVT LTD. (ACPL) 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 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)

11. www.acplgroupindia.co.in ACCREDITED CONSULTANTS PVT LTD. (ACPL) ACCREDITED CONSULTANTS PVT. LTD. (Email: bhatbio@gmail.com, info@acplgroupindia.co.in)bhatbio@gmail.cominfo@acplgroupindia.co.in (Website: acplgroupindia.co.in) (Contact: +91 22758204, 9350040434, 9310040434, Fax: 22758994) D-29, 1 ST FLOOR, ACHARYA NIKETAN, MAYUR VIHAR PHASE-I, NEW DELHI-110091