Supplier/Third Party Audits
Assess for initial & periodic third party audit of APIs, intermediates, excipients, packaging materials, medicinal products, medical devices, and cosmetic ingredients manufacturers/supply chain against applicable global regulatory standards, including US 21 CFR, EU GMP, ICH Q7, PIC/S, ISO, IPEC, and Schedule M.
For Cause/Focused Audits
For Cause/focused audits of medicinal products and medical devices as per ISO 13485, US 21 CFR Part 820, and EU GMP Part I, ensuring compliance.
Internal Audit & Mock Regulatory Audits
Prepare for official inspections (WHO, USFDA, EU GMP) with rigorous mock audits to ensure full readiness and identify gaps.
/ GxP Quality Audits
Provide regulatory-compliant audit reports, customized reports aligned with client requirements or SOPs, existing audit reports for immediate needs, and support through global partners for urgent audits and reporting.
Deliver focused audit reports with critical findings, root-cause assessment, compliance gaps, and CAPA recommendations aligned with regulatory and client requirements.
Deliver audit reports with critical findings, root-cause assessment, compliance gaps, and CAPA recommendations aligned with current regulatory expecations.
/ Contract Manufacturing Quality Assurance
Contract Manufacturing (CMO) Quality Oversight Services for Marketers
CMO Qualification & Quality Oversight
Phase-wise and customized CMO evaluation covering technical assessment of products, CMO risk evaluation against client URS, regulatory-compliant audits and qualification, onsite quality oversight during commercial manufacturing, GMP-compliant batch release, and ongoing product lifecycle management, including CMO performance monitoring, market complaint handling, and product quality reviews.
/ Build Competency
Specialized Technical Training Programs
Investigation & Root Cause Analysis
Computer System Validation (CSV)
Internal Auditor Qualification
Cleaning Process Design & Validation Methodologies
Training on investigation methodologies, root cause analysis tools such as 5-Why, Fishbone, FMEA, and Fault Tree Analysis, deviation assessment, CAPA, and investigation documentation.
Training on risk-based CSV methodologies, validation lifecycle, data integrity, electronic records, validation documentation, and maintaining the validated state in compliance with GxP requirements.
Certify professionals to conduct effective internal GxP audits, strengthening your organization's self-assessment capabilities.
Comprehensive training on pharmaceutical cleaning process design, covering risk-based cleaning strategies, selection of worst-case products and equipment, acceptance criteria, sampling techniques, analytical methods, cleaning validation protocols & reports, and lifecycle approach.
Equipment/ Utility Qualification Methodologies
Comprehensive training on equipment and utility qualification methodologies, covering risk-based qualification strategies, URS, DQ, IQ, OQ, PQ, qualification protocols and reports, acceptance criteria and lifecycle approach.
Good Manufacturing Practices (cGMP)
Training on core cGMP principles covering quality systems, personnel, premises, equipment, production, documentation, quality control, validation, deviations, CAPA, change control, and self-inspection in line with applicable GMP guidelines.
Supplier Qualification Methodologies
Training on risk-based supplier qualification covering supplier assessment, due diligence, audits, quality agreements, risk classification, performance monitoring, requalification, and ongoing supplier oversight in line with applicable GMP requirements.
Train-the-Trainer Programme
Training on effective training delivery, instructional techniques, training needs assessment, presentation skills, adult learning principles, assessment methods, and training effectiveness evaluation for GxP environments.
Initiate project-based or continuous support engagements models with Archieto Pharmacorp
A defined, time-bound engagement for a specific quality oversight project, with an agreed scope, deliverables, timeline, and fixed project fee.
An ongoing quality oversight partnership under an annual subscription, providing continuous access to agreed services across multiple activities or projects within a predefined scope and service capacity.