Testimonials And Cases of VIaTAL Pharma Consultancy (VPC)
An overview of a few of the cases handled with excellent results
- Goa-based manufacturing topicals plant has been audited for EU-cGMP compliance with GAP analysis report and basic CTD training imparted to all heads of the department.
- A large Mumbai based company asked VPC to make a superfine CTD from very old dossier typed copy about 12 years old data
VPC preliminary scrutinized the entire file starting from development to composition to Manufacturing, analysis, packing style, artwork , any clinical or toxicology studies. The company associated with CRAMS got product pilot and production batch and we compiled entire dossier with biowaiver report.
3 such dossiers were made and got fully submitted and got change of ownership transferred license.
- A UK-based firm seeked us to audit API companies in India to be used for their formulation.
VPC studied all API company manual, set agenda as per ICH Q7A /cGMP guidleines, send checklist to company under audit, completed audit, gave analysis, report and follow on dates. The reports were accepted by UK-MHRA.
- A Danish-based company in In India wanted us to be their specialist to travel to CPhI –EU-worlwide to get business.
We were successful in obtaining good business contacts and deals for this Danish company
- A MNC based in India sent us request for getting all expert info to use SmPC to make final user tested leaflet assistance
and primary secondary literature for some EU and PAN-ASEAN territories.
- An oncology based Indian company had made us their prime contacts to Ministry of Healths to Tanzania, Peru, SantoDomingo, Costarica, Kenya , Panama .
These are for llyophillised powdered injections and tablets. We had resolved the Response for further information in very efficient manner and obtained variation approvals, licenses for all the applications within short span of time.
- A Chennai based company in joint collaboration with UK-firm asked us to assist with entire Pharmacovigilance set and make it compliant to inspections.
We have trained, made all documents, helps them in setting PSURs, signals, CIOMS logs, Adverse reaction log. SOPs etc. Our presence was also made in the ACTUAL INSPECTIONS . It was successful
- A antibiotic oral dosage firms company wanted us to do various Type-II complex variations for tablet diameter
We arranged to submit to EMEA with all BMR/BPR, Form Compilation, F1/F2 expert invitro-dissolution report, tablet diameter trend analysis sheet and 3 production batches analysis and justification for the change. Successsful in getting type -II approval
- A International MNC Company in India were seeking to train their senior managers on New Regulatory approach for Regulated and ROW Markets
VPC successfully trained for a week complete Regulatory overview and Modules 1-5 step by step for a batch of 50 candidates
