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GMP auditing and inspection for the pharmaceutical supply chain. Flexible GMP and GDP pharmaceutical auditing solutions, helping you to improve control over quality for your complex supply chains. Our GMP auditors evaluate and monitor your suppliers, subcontractors, and service providers supporting your pharmaceutical product lifecycle.
GMP audit and inspections for pharmaceutical industry suppliers and subcontractors remain a critical part of the drug development and manufacturing process.
An experienced GMP auditor who can evaluate and monitor supply chain stakeholders, can drive greater insight which enables you to improve control over quality. All regulatory agencies who set standards for the pharmaceutical industry have an expectation of Good Manufacturing Practice compliance, for example, across production supply chains. As a consequence, you will have an obligation to engage with your increasingly complex supply chain, and all supply chain actors including a multitude of suppliers, service providers and subcontractors.
Our team of senior GMP auditors, who are located around the world, have in depth experience of conducting pharma audits to GMP, knowledge of the pharmaceutical regulatory standards, expectations and procedures. We conduct regulatory GMP and GDP audits in the pharmaceutical industry against the applicable regulatory texts or standards such as Good Manufacturing Practice (GMP), Good Distribution Practice (GDP).
We also audit against IPEC guidelines for Pharmaceutical excipients, ISO 22716 (Cosmetics — Good Manufacturing Practices), EFfCI GMP for cosmetic ingredients, ISO 15378 standard for packaging materials, ISO 9001 standard or EHPM Quality guide for food supplements. With robust internal procedures, our quality system and our auditor qualification process, driven by our Quality manager, is regularly audited by our clients with positive outcomes of reliability and robustness.
Flexible private or individual pharmaceutical audit solutions, shared audits, CAPA evaluation and follow-up, audit report purchase, remote or virtual audits and support for your internal audit program. We audit suppliers and manufacturers of APIs, excipients, packaging materials and other materials, subcontractors of manufacturing, packaging, analytical testing, transporters, IT service, cleaning service and all other services.
The pharmaceutical industry continually faces increased focus and inspections by health authorities, coupled with travel restrictions and complex globalised supply networks. This all increases the demand on your supplier’s time to take part in GMP compliance audits and inspections and the need to meet ever-expanding regulatory expectations.as your audit partner, we help you to overcome these challenges. Our solutions, such as our GMP audit services or our shared audit platform, can reduce demands on time and resources for all stakeholders in the supply chain by combining the requests to audit a particular supplier site. This in turn can help to optimise your budget through reduced audit costs.
Among other services, RegPharmaClin S.L. acts also as the Contract Research Organization (CRO, Services provider) for clinical trials. We are always aware and up-to-date with the GCP requirements and possess a qualified team of GCP auditors, who can perform independent assessment of clinical trial(s). We provide auditing services to support regulatory compliance (on site or remote, GCP inspections conducted remotely to Specifications) for your clinical development programme, from Phases I to IV.
Our highly experienced, trained and competent team of specialist GCP auditors has conducted thousands of audits in all therapeutic areas, according to international and national regulations, in over 100 countries. Continual positive client feedback is evidence of our professionalism and competency. The conduct of GCP quality audits is becoming an increasingly challenging process, owing to the complexity of clinical trials and the location of investigator sites.
Although the majority of sponsor organizations reside in Europe, the USA and Japan, their clinical trial sites are often located in Asia, Africa, South America, the Middle East and the Far East. Not only are auditors challenged with physically reaching the investigator sites, but they also have to deal with the diverse cultures they encounter.
RegPharmaClin S.L. has a global reach with staff based across four continents. Not only does this help with language and cultural barriers, but also the travel time and cost for the conduct of these audits.
We Assess compliance with FDA/EU regulations and ICH guidelines
We can help you in selecting the CRO and vendors to perform your study, or verify if the already selected CRO/Vendors runs the trial appropriately.
Each audit will start with the creation of a detailed Audit Plan and followed by a comprehensive and confidential Audit Report. An Audit Certificate will also be provided.
If required by the client, involvement in follow-up activities of each audit (e.g. Corrective and Preventive Action (CAPA) review, acceptance, follow-up steps) can be contracted.
In addition to auditing, RegPharmaClin S.L. also provides consulting on strategic audit plans design. We can advise in the development of your company audit program to ensure compliance with regulatory requirements. A good audit program will demonstrate adequate quality oversight and management of quality issues.
Preparation of the full Dossier to setup a Laboratory in Spain according to GMPs and GDPs for Biotech, ATMP, IMP and medicinal products including sterile compounds (Personnel Qualified for the Role of QP and Technical Responsible) and installation approval for cosmetics, medical devices (Technical Responsible and Person Responsible for Regulatory Compliance), nutraceuticals (Qualified Personnel to be a Marketing Responsible, Local Representative, Contact with Distributors).
Assist clients to set up ISO 9001:2015 and UNE-EN ISO 13485:2018/A11:2022