Pharmacovigilance

Review & maintenance of PV System Master File (PSMF) with complete Annexures in compliance with EU guidelines

Registration with Eudravigilance and related activities

Review, approval & submission of PBRERs / RMPs etc

A single point contact to the Regulators for all Drug safety related queries for client products

Development of Pharmacovigilance Master File (PSMF)

Risk Management Plans (RMPs)

Aggregate Report Writing

Periodic Safety Update Report (PSUR) / Periodic Benefit-Risk Evaluation Report (PBRER)

Periodic Adverse Drug Experiences Report (PADER)

Development of CCDS /Label Management

CSR Writing

Protocol Writing

Eudravigilance Services

Developing training matrix, plans & training material

Conducting 'Boot Camp' and training stake holders in a MAH set up

Customized training on Good Pv Practices, Safety Regulation Updates, etc

Providing customized training material & Corporate Training

From developing project plan, then transition through setting up pilot phase and establishing SLA with client.

Facilitating deployment & validation of safety software

Developing necessary documents such as core SOPs, checklists, templates.

Developing Standard Operating Procedures & Work Instructions

Developing training material & conducting PV training for incumbents

Developing Master Quality Plan & internal audits.

Helping clients with selection of safety database like ARISg & ARGUS, and facilitate installation, validation, dry runs till going Live.

We also help develop innovative tools such as e-trackers for monitoring productivity, quality & SLAs

Registration of MAHs & E-submission to various HAs

Data Migration, validation

Literature Search

eTMF/TMF file reviews

Conducting PMS Studies

ICH GXP training modules

Inspection Readiness training For Site and CRO (Sponsor) personnel

Mock Inspection

Assistance in CAPA preparation

Development of Standard Operating Procedures, Work Instructions, Templates, for all PV related activities. We also help develop innovative tools such as e-trackers for monitoring productivity & SLAs