AMPLEXOR Helps Fortune 100 Pharma Firm Address Major Regulatory Compliance Issue

    Many pharmaceutical companies face challenges in the face of local language deviations and changing regulations. In order to better meet these challenges, a customer enlisted the help of AMPLEXOR Life Sciences.

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    As a company that works extensively with both medical device and drug manufacturers on a global basis, AMPLEXOR Life Sciences is only too aware of the compliance challenges that come with labeling of products.

    Labels must comply with regulation at both a global and local level and it is a process that is vulnerable to error, with local translators potentially misinterpreting what’s in the prime reference document. At other times, extra information might be needed for a label because of country-specific requirements by the local health authority.

    It can be a complicated and high-risk situation for the pharma company that must translate labels into so many different languages, which is why we are so proud of the work we did recently with a Fortune 100 pharmaceutical firm and one of the most recognizable names in the industry.

    The challenges of a decentralized model

    Translation issues are most likely to occur in a decentralized model. Local firms are appointed to manage translation and localization of labels for their own markets, but this creates potential headaches for the global regulatory team – how can they be sure that local labeling is compliant with both minimum company requirements and local health authority requirements?

    That was the situation facing our customer. They had lost sight of the state of the local labeling of its products and did not know what was being submitted to local health authorities, which meant that labels might carry different, incorrect or misleading instructions to patients.

    The customer conducted field tests into any such discrepancies, the results of which made them realize they needed additional assistance. They then turned to AMPLEXOR Life Sciences to create a solution to identify instances of non-compliance in local labeling and correct any discrepancies in order to achieve regulatory compliance in all current markets.

    An extensive translation project

    The project scope was vast, as it encompassed the company’s entire global drug portfolio, which included around 100 countries and 50 different language combinations. The company had worked through a traditional labeling process, but AMPLEXOR Life Sciences quickly realized the process needed to address the specific requirements did not exist and needed to be created. This was done by breaking them into three areas:

    1. Retranslate: Translate all local labeling back into English. This required 400 linguists to translate almost 3,500 files for labeling, and more than 13 million into English.

    2. Linguistic review: Review of all translated Prescriber Information and Patient Information Leaflets to assess compliance with Reference Safety Information documents. This review consisted of 1,370 files.

    3. Labeling assessment: Pull all current active artwork – defined as anything that ships with the drug such as Patient Information Leaflets, Prescriber Information, bottle labels, cartons, blister packs, pre-filled syringes, packaging, and pouches – to identify errors in labeling. AMPLEXOR Life Sciences developed a 20-hour training course that required the linguistic assessors to methodically check each piece of artwork against a very detailed assessment template.

    Full compliance delivered

    At the end of the 18-month project, AMPLEXOR Life Sciences had helped the customer to achieve full compliance, keeping it out of trouble with health authorities and saving it potentially millions of dollars in fines for non-compliance.

    Not only did the customer pass its Health Authority inspection with praise from the inspector, but it also benefitted from some powerful financial savings, both for translation memory and process refinement. 

    Compliance is unquestionably one of the biggest challenges facing large pharmaceuticals, with the penalties for non-compliance too damaging to even contemplate. The results for this customer were achieved because of AMPLEXOR Life Sciences’ innovative thinking and creative problem-solving and the team played a pivotal role in ensuring compliance for this Fortune 100 pharmaceutical firm.

    The full case study of this project can be found here, or for further details of our unique software and services in this area, please visit here.

    Published on 29/03/19    Last updated on 29/03/19

    #Labeling

    About the author

    Kathleen O’Brien is Director of Business Development with AMPLEXOR Life Sciences and a 15-year veteran of the translation industry. Kathleen has a background in linguistics and has held various roles in the translation business: vendor, project and account management, as well as new business development, giving her a unique perspective into both translation operations and how translation impacts the globalization needs of her clients in the pharmaceutical and medical device industries. She proactively collaborates with her life sciences client partners on a daily basis to help them set their localization strategies.

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