Services
Pharmacovigilance (PV):
a) System set-up :
Helping, facilitating, small & mid size pharma companies to set up PV &
PV QA function from the scratch or scale up existing PV system. This encompasses…
● Establishing an organogram
● Identifying & defining Roles & Responsibilities (Job descriptions)
● Development of Standard Operating Procedures, Work Instructions, Templates,
forms related to PV & PVQA function
● Development of Quality Management System includes Master Quality audit Plan,
Risk based Internal Audit Strategy, distributor audit strategy,
● Support in setting up database for change control, deviation & CAPA management
● System validation Safety Database
● Training of safety team, PV QA team, Safety Officer & other stake holders
(physical/Remote).
b) PV audit & Inspection services:
● Complete range of PV audits physical/ Remote including System Audit, Vendor Audit,
Distributor Audit, Affiliate Country Office, Other department (such as Regulatory, IT,
manufacturing site etc.) providing support for PV related activity with
recommended CAPAs & Audit Certificate in any geography.
● Facilitate MAH for Inspection Readiness & assistance in preparing MAH’s responses
to Inspection findings
Other GXP (GCP, GMP, Pharma IT) services:
a) System set-up :
provide support to set up Clinical Research Development (CRD)
department & CRD QA function from the scratch or scale up existing CRD system. This
includes..
● Establishing an organogram
● Identifying & defining Roles & Responsibilities (Job descriptions)
● Development of Standard Operating Procedures, Work Instructions, Templates,
forms related to CRD & CRD QA function
● Development of Quality Management System includes Master Quality audit Plan,
Annual audit charter, Risk based Internal Audit Strategy, site audit strategy, vendor
audit plan
● Support in setting up database for change control, deviation & CAPA management
● System validation Data management soft ware
● Training of CRD team, QA team, Site staff & other stake holders (Physical/Remote)
b) Audit & Inspection services:
● Investigator Site audits
● GCP System audits (Sponsor and CRO)
● CRO audits (due diligence audits)
● Vendor Qualification Audits
● Phase 1 audits
● Investigational Product Supply and Management audits
● IT system Qualification audits
● Archival site audits
● Drug Destruction Unit audits
● Data Management Audits
● For cause Investigator Site audits
● GMP Audits for Clinical Research aspect
● Regulatory Affair audit
● Facilitate Sponsor for Inspection Readiness & assistance in preparing Sponsor’s
responses to Inspection findings
Trainings:
● 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, GCP, Site team
etc.
● Providing customized training material & Corporate Training
Software validation:
● Helping clients with selection of safety database like ARISg & ARGUS, and facilitate
installation, validation, dry runs till going Live.
● We also help establish e modules for training, change control, deviation and CAPA
management
● Data Migration, validation
Other services:
● ICH GXP training modules
● Inspection Readiness training For Site and CRO (Sponsor) personnel
● Mock Inspection
● Assistance in CAPA preparation