Safe Drug For Humanbeing

Pharmavigil India is a global Pharmacovigilance Consulting company incorporated in India

in 2015 and in the United Kingdom in 2016. We are offering advisory and outsourced support
to the pharmaceutical, biological and medical device industry.
Core team members of this company having a decade of experience in pharmacovigilance,
medical writing, medical literature monitoring and regulatory services. We are capable to set
up and host your drug safety database and write your SOPs.
Noteworthy, medicine is a double edged sword either saves life or kills life. Safety of
medicine is a serious concern and it depends how you care medicine on all distribution points
from manufacturing to distribution, distributor to retailer, retailer to patient and storage
condition in different points. Second most import thing how clinicians respond to the
company regarding adverse effects of medicine and how vigilant a company in collecting and
responding to the regulatory body and to the society. Let us pledge safe drug for all global
citizen. Our service include Pharmacovigilance, Medical Writing & Regulatory Affairs
PHARMACOVIGILANCE
Pharmavigil is dedicated for patient safety for pharmaceuticals, biotech and medical device
companies to meet drug, vaccine and device vigilance obligations. Our team are trained and
expertise working with leading pharmacovigilance and regulatory companies.
Our vision and business model are focused on attaining leadership in the areas of
Pharmacovigilance. We have hand on experience of European Medicines Agency, US,
Canada, Japan, Latin American Countries, Asian, CIS and Middle East countries. Our team is
trained with Argous, EUdravigilance
Our team has the proven ability to advise and manage variety of pharmacovigilance projects
and arededicatedto deliveringthehighestquality support. Our commitment goes hand in hand
and in cost-effective manner.We offer the following pharmacovigilance services:
Single Case Processing (ICSRs) of adverse events
Quality Review of ICSRs
Aggregate Report writing (PSURs)
Global Medical Literature Monitoring
Risk Signal Detection & Evaluation
Reconciliation of Serious Adverse Events
Safety Case Narratives
Risk Management Planning (RMP)
Risk Evaluation Mitigation Strategy (REMS)
Pharmacovigilance System Master File (PSMF)
PV Quality Assurance including SOP development

PV Compliance & Auditing

PV Inspection Readiness
Quality Person for PV(QPPV)

MEDICAL WRITING
All
new drugs go
through
the
increasingly
complex
process
of clinical
trials and regulatory procedures that lead to market approval. This demand for the clear
articulation of medical science drives the demand for well written, standards-compliant
documents that medical professionals can easily and quickly read and understand.
Medical writer requires special skill to produce well-structured documents that present
information clearly and concisely. We have hand on experience of writing following
customised services for your organisation:
Monthly Referenced Newsletter
Manuscript Review
Product Monograph/Manuals
Customised Book on disease/Treatment
Bioequivalence protocol-writing & review
Clinical Trial Protocol- writing & review
CRF & ICF Writing and reviews
Literature & Visual Aid
Physicians Query Reply on medicine
Customised Book on drug and disease
REGULATORY AFFAIRS
Regulatory department plays vital role in registering product on time with quality and
commitment. You require a trusted partner for compilation of dossier and to response query
of time.
Retaining and regular training is a challenging job for any company because it over burdens
financial department and human resource department and ultimately delay the process of
registration.
We honour your trust and ready to support in registration of your product and after in
submission service. Our regulatory service is more than a decade old and we have core
competency in this domain. We are compiling dossier for highly regulated, regulated and
semi-regulated market.
We can assist you in reviewing your ready dossier for submission to the drug department. We
will also assist you in translation of dossier as per your requirement. We have hand on
experience of ACTD, CTD and e-CTD dossier.
We are here to support you for getting no objection certificate from CDSCO for
bioequivalence and clinical trials. We review your documents before submission to reduce
the chances of query and assuring timely approval.
Updated on 18/02/2016

You can reach us via email pharmavigilindia@gmail.com, Mob: +91-9818131498