GlOBAL AT HEART, LOCAL IN SPIRIT

Ideolon offers comprehensive and tailored solutions in supplier auditing with globally present quality compliance consultants who use diverse language skills and technical prowess to ensure quality as well as optimize cost and time.

Ideolon provides comprehensive 360-degree solutions to fulfil GxP requirements, spanning from initial development of drug to its post-marketing phase. The team of more than 70 subject matter experts from 15+ nationalities brings diverse regulatory expertise and years of experience to offer unbiased quality driven solutions.

Audit Approach: Review of Practice to Procedures

At Ideolon, our ideology goes beyond mere review of SOPs. We are committed to ensure compliance of appropriate procedures with a strong emphasis on rigorous practices.

Global Auditing Program- One Point Management

Navigating the global presence of suppliers brings a range of challenges, including language and geographical barriers, as well as reduced operational efficiency and coordination. Ideolon presents unique operational solutions designed to efficiently monitor, enhance, and simplify the auditing process within specified timeframes.

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PRE-INSPECTION AUDITS

Perform Mock or Readiness Audits with our experienced Ex-Regulator Auditors from USFDA, EMA, PICs, ANVISA.

DUE DILIGENCE AUDIT

Audits for mergers & acquisitions. Customers get a comprehensive understanding of target companies' quality systems, potential risks and the area that requires remediation. This service further leads to risk mitigation and optimization of the due diligence process.

SUPPILER QUALIFICATION GMP AUDITS

Comprehensive GMP auditing solutions tailored to specific needs. End to end complete package with assurance of independent quality-oriented assessment of your suppliers. We are specialized in conducting audits of FDFs, APIs, Excipients, Key Starting Materials, Warehouse and distribution.

GXP AUDITS

To ensure the compliance of product life cycle, we offer solutions for performing GCP (Good Clinical Practices), GVP (Good Pharmacovigilance Practice) and GDP (Good Distribution Practices from the CROs to Warehouses.

INDEPENDENT AUDITS

Our services offer valuable time-saving benefits for suppliers. We conduct comprehensive on-site audits that encompass the entirety of the site, including the quality management systems of key products and facilities. While prioritizing confidentiality, we deliver audit reports in a cost-effective manner.

TAILOR SOLUTIONS

Each audit has different approach and auditee has different history. We customize our approach based on the audit needs technically and commercially.

SOLUTION BEYOND BOUNDARIES

Having our strongest root in Asia, Ideolon has expanded globally with 14+ nationalities and 50+ auditors on board across the world, from Japan to USA. Our solutions transcend country borders.

ONE STOP SOLUTATION

Leveraging our robust global footprint and extensive regulatory expertise, we streamline audits with our user-friendly one-click solutions model. This guarantees the execution of processes in a timely sequence while ensuring regular customer updates along the way.

EQUITABLE

Our audits are conducted with unwavering impartiality and objectivity. The auditor evaluates specific parameters and communicates them to the auditee in a transparent manner. We diligently uphold the absence of any commercial affiliations between the supplier and auditee, ensuring a fully unbiased audit process.

SAVE TIME & RESOURCE

Through our comprehensive end-to-end consultation model, we enhance time efficiency and optimize resource allocation. Our user-friendly tracking models and regular updates guarantee that Ideolon functions like your team member, despite being situated in a different geographical location.