Complete Case Management
ADR Case Processing, Reporting & Submissions 24/7/365: Drugs, Vaccines, Medical Device, Cosmetics & Nutritionals
- Book in, Triaging & 24/7/365 Case Management Support.
- Data entry into validated electronic PV database.
- 100% Quality control of all ICSR including medical QC.
- Medical review and assessment, narrative writing, MedDRA coding.
- Product Quality Complaints Management.
- Reporting & Submissions: Electronic (E2B), Hard copy (CIOMS, MedWatch 3500A drug, etc.) to worldwide regulatory authorities.
Literature Review, Search & Monitoring
Safety Data Exchange Agreement Management
- Authoring and preparation of SDEAs customized per global regulatory requirements.
- Review of SDEAs.
- Negotiating safety aspects to be included in the SDEAs with business partners.
- In-house Web based Safety Data Exchange platform, “STREAM”.
Provision and Support with EQ-QPPV and DQPPV
- 24/7/365 Support with EU QPPV & DQPPV Good PV Practice Modules (GVP) –
New EU PV Regulations.
- Oversight of the PV System in terms of structure & performance to ensure appropriate collation of ADRs, preparation and sign off of regulatory documents (PSURs etc) and Post-Authorisation Safety Studies (PASS Studies).
- Ensuring all requests from Regulatory Authorities are answered completely and promptly.
Signal Detection – Benefit Risk Evaluation
- Support with Identification and Prioritization of Signals from company databases.
- Complete work up of signals including, signal evaluation, epidemiological input and closing of signals.
- Authoring of Signal Evaluation Reports (SERs) or Issue Work Ups of signal for regulatory submission.
- Communication of Signals to Regulatory Authorities and Prescribers.
Clinical Safety Management Services
- MedDRA Coding and Data Analysis
- Reconciliation of Clinical & Safety Databases
- Migration of Data and Legacy data from various databases
- Generation of CIOMS Line Listings
- Data Mining from various databases
Drug Safety/Pharmacovigilance Services for different phases
- Safety Support for Different Phases
- Preparation of Medical Management Plan
- Preparation of Safety Management Plan
- Preparation of Safety sections of eCTD for NDA, IND & BLA submissions
- NDA, IND and BLA Safety Review
- Compassionate Use Programs Support & Monitoring