PHARMALANE UK Ltd. is a Global Pharmaceutical (GxP) Auditing Consultancy registered in the Registrar of Companies for England and Wales UK, with the company registration no. 13629514.
The paramount motto of the company are:
PHARMALANE UK is a well-established and ISO 9001:2015 certified GxP auditing consultancy specializing purely in Pharmaceutical Quality Auditing, such as GMP, GDP, GCP, GLP, GPvP for the clients across the globe. We also have a database of over 600 (increasing monthly) ready GMP audit reports to be procured hence providing Ready GMP Audit Reports of suppliers (if available) is also our major segment of the service. We have our registered office and Head Quarter in London, United Kingdom; we also have our registered office in Asia with global organisational structure. Our consultants/ auditors also are based globally including UK, EU, Asia and USA to cover the maximum parts of the world.
The PHARMALANE UK is now a GLOBAL LEADER specifically in GMP auditing with combine experience of over 15 years in the Pharmaceutical & Auditing Services across the globe. PHARMALANE UK is formed by merger and rebranding of two very professional and global consultancy companies i.e. ARC Pharma UK Ltd. (Services segment) and CRYSHTA Pharma Consulting. This merger has expanded PHARMALANE UK’s global presence across the UK, Europe, Asia, and the USA.
We have proven our outstanding expertise and services to over 500 clients (Pharmaceutical companies) in more than 40 countries.
To become the most RELIABLE and ONE STOP SOLUTION partner for pharmaceutical companies globally to fulfil their all GxP Audits need; to achieve cent percent CUSTOMER SATISFACTION by efficiently delivering superior quality of services which customers can rely on. Not only being a Service Provider but we also aim to be an integral part of our customers’ Quality Organisation to enable them in supplying the highest standards of medication to the patients worldwide.
PHARMALANE UK has a team of full time employees based out in UK as well as in Asia offices with diversified knowledge and extensive global experience in Audit Management, Audit Performance, Audit Reporting, Report Reviewers, Subject Matter Experts (SMEs) and admin staff to support our clients for their Audits need.
We have a team of over 100 highly experienced and qualified auditors and consultants, accredited by internationally recognized auditing bodies. Our auditors, located across the UK, Europe, Asia, and the US, are equipped to meet the diverse needs of our global clients. Most of our consultants and auditors hold certifications from prestigious organizations such as IRCA-CQI, ASQ, BSI, APIC, ECA etc.
We have implemented strict AUDITORS’ QUALIFICATION PROCESS which has to be embedded with by our Sr. Management before signing off any professional as our Qualified Auditor; detailed confidentiality agreements are also signed with each of the consultants perform the audits as per our AUDITOR’S CODE OF ETHICS and maintain full confidentiality.
We have implemented very effective and strict procedure for the NEW AUDITOR QUALIFICATION and only after satisfactory evaluation, person can be considered as “Qualified Auditor” of PHARMALANE UK; below is high level steps of how we do that:
Evaluate the received a candidate’s profile
Analyze the experience/competency of the candidate with respect to Quality auditing
Conduct interview by Head of the Audit and subject matter experts
Do background check through various mediums
Once satisfactory, get the CDA signed with the candidate
Observe 1-2 audits (if needed) to verify auditing techniques
Consider the auditor as QUALIFIED for the specific type(s) of audits (based on experience)
Routine monitoring of the Auditor’s status; yearly re-evaluation
Our Audit Report Package is very thorough and includes all of the following which is sufficient enough to qualify the supplier:
