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Current company Pharmexpert Consultant Llp
Business Consulting and Services · 24 employees · Founded 2017 · Ahmedabad, Gujarat, India
Pharmexpert is purely a knowledge based consulting company who has been serving Pharmaceutical Clients in various domains across the Globe since last 2017. Our service portfolio includes GMP, Facility Designing, Certification program, Supplier Qualification Audits, GMP training, Pharmacovigilance, Regulatory services and BA BE Clinical trial, etc. We have a team of Subject Matter Experts from different segments of the industry like GMP, Quality, R&D, AD, IT, PV, RA, GCP & Engineering. All our consultants/auditors and subject matter experts are highly qualified professionals; the expertise varies from the range of 12 to 35 years of core experience in the area of Specialization. Our consultants/ auditors are also based in other countries to cover the maximum parts of the world. GMP & Engineering: • GXP Audits: o Third Party / Vendor Audit;(API/Excipients/KSMs/ raw materials/Packaging material/ cosmetics/Medical Device /Contract testing Laboratories) o GAP Audit o Root Cause Identification audit o Pre-inspection / Mock Audit o Due – Diligence o Data Integrity Risk based assessment (DIRA) o Environment, Health and Safety (EHS) Audit o CSV Audit o Good Laboratory Practice Audit (GLP) o Good Clinical Practice (GCP) audits • Audit Report Library • Independent GMP Audit Program (IGAP) • Compliance & Upgradation-GMP Upgradation of Site in compliance with USFDA, EU GMP, PIC/S, WHO GMP and Other Regulations • Conceptual, Basic and Detailed Engineering • Commissioning & Qualification (C&Q) • Validation • GMP Consulting : o Pharma Plant Set-Up o QMS set up o QP Services o Sourcing o Regulatory Affairs o Training o Monitoring o Contract Mfg. o Business Support • Procurement Support • Computerized System Validation • Business Continuity & Operational Excellence. • Sourcing : Regulatory Affairs services Research & Development (R&D) services. Pharmacovigilance services. etc. Your one stop solution for providing GXP services.