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

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

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

ACCREDITED CONSULTANTS PVT LTD. (ACPL)

ACCREDITED CONSULTANTS PVT LTD. (ACPL)

WELCOMES YOU

Your PHARMACOVIGILANCE PARTNER

Page 2: 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)

Page 3: ACCREDITED CONSULTANTS PVT LTD. (ACPL) WELCOMES YOU Your PHARMACOVIGILANCE PARTNER

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)

Page 4: ACCREDITED CONSULTANTS PVT LTD. (ACPL) WELCOMES YOU Your PHARMACOVIGILANCE PARTNER

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

Page 5: ACCREDITED CONSULTANTS PVT LTD. (ACPL) WELCOMES YOU Your PHARMACOVIGILANCE PARTNER

www.acplgroupindia.co.in

Consulting Services that meet your needs

ACCREDITED CONSULTANTS PVT LTD. (ACPL)ACCREDITED CONSULTANTS PVT LTD. (ACPL)

Page 6: ACCREDITED CONSULTANTS PVT LTD. (ACPL) WELCOMES YOU Your PHARMACOVIGILANCE PARTNER

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

Page 7: ACCREDITED CONSULTANTS PVT LTD. (ACPL) WELCOMES YOU Your PHARMACOVIGILANCE PARTNER

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.

Page 8: ACCREDITED CONSULTANTS PVT LTD. (ACPL) WELCOMES YOU Your PHARMACOVIGILANCE PARTNER

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)

Page 9: ACCREDITED CONSULTANTS PVT LTD. (ACPL) WELCOMES YOU Your PHARMACOVIGILANCE PARTNER

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.

Page 10: ACCREDITED CONSULTANTS PVT LTD. (ACPL) WELCOMES YOU Your PHARMACOVIGILANCE PARTNER

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)

Page 11: ACCREDITED CONSULTANTS PVT LTD. (ACPL) WELCOMES YOU Your PHARMACOVIGILANCE PARTNER

www.acplgroupindia.co.in

ACCREDITED CONSULTANTS PVT LTD. (ACPL)ACCREDITED CONSULTANTS PVT LTD. (ACPL)

ACCREDITED CONSULTANTS PVT. LTD.

(Email: [email protected], [email protected])(Website: acplgroupindia.co.in)

(Contact: +91 22758204, 9350040434, 9310040434, Fax: 22758994)D-29, 1ST FLOOR, ACHARYA NIKETAN, MAYUR VIHAR

PHASE-I, NEW DELHI-110091