VIBGYOR Pharma Consultants
Sarve Bhavantu Sukhina, Sarve Santu Niramaya !
About Me
Nearing three decades of experience with Life Science industry - Pharma, Bio-Pharma, Medical Devices, CSTM (Clinical Supplies Trial Material), CTL (Contract Testing Laboratory).
Successful management of Regulatory agency inspections and audits by USFDA, MHRA, EU, TGA, DCGI (CDSCO), WHO Geneva, ANVISA, GCC, ISO audits, NABL etc.
Certified Performance Coach/Mentor and Life Coach
Certified Quality Engineer, ASQ
Laboratory Lead Assessor ISO 17025
Lead Auditor ISO 9001
Trained on RQA in GLP by BARQA, UK
Trained on GLP (OECD), GCP (ICH) and QA in BA Setup, Belgium.
Paper presenter at International Conferences, have many National/State level recognitions, Resource person, Speaker, Question Paper setter and External Examiner.
Let's explore... beyond the door... what I have for you
Consulting Services
I work with clients, providing exceptional consulting services that are catered specifically to their needs. Take a look below at the services I offer and get in touch to achieve results.
Quality and Regulatory challenges - helping organizations to sail through it.
Regulatory agency inspections and audits - its successful E2E management, including audit preparedness, response / exhibits - preparation and review.
Regulatory Affairs - Development of Regulatory strategies and providing guidance and consultations for regulations (GxP, MDR etc.).
Third-party audits, GMP audits and Internal audits - conducting and helping in audit compliance and time closure.
Project management - Green field to high yield.
Liaison - with Regulatory authorities, Collaborators, Business associates, Financiers and other Government bodies/officials.
Management Information System and Quality Metrices
Scale up & Technology transfer - assistance from R&D to Plant
Technical collaboration assistance
Developing QSP for commercial departments - like Imports, Exports, Marketing, Purchase, etc.
Trainings & Validation - Help to build an empowered and talented work force and support all validation activities.
For Life Coaching - visit www.vibgyorlifecoaching.com
Contact Me
Have a particular challenge you’re trying to deal with? Contact me today and see what I can do for you.
Dera Bassi, Punjab, India
+91 9130085885