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B R O C H U R E

Bringing expertise to promotional compliance activitiesGlobal and local challengesPromotional-material requirements place huge burdens on life sciences companies. From international codes of conduct to European directives, to laws and regulations at the local level, marketing authorisation holders and medical device manufacturers must make sure they are compliant with many different requirements and that their communications are consistent across all countries.

The activities required to ensure promotional materials meet compliance requirements span many different functions. At the preapproval stage and the corporate level, the process begins with the development of promotional materials by marketing, after which the materials are reviewed by medical affairs before going to regulatory for further review and for validation Once the materials go to local markets, companies must be sure to have the affiliate-level resources and expertise necessary to manage the review process according to local requirements before submitting to national competent authorities (NCAs) if required.

ProductLife Group’s promotional-material expertiseProductLife Group brings 25 years of experience in regulatory activities, including meeting global and local requirements for the management of both promotional and nonpromotional materials.

Led by a team of regulatory and legal compliance experts with global project coordinators, ProductLife Group manages every aspect of the production of promotional materials and of meeting legal compliance for clients in accordance with international guidelines and local regulations.

During a global project, a project coordinator oversees the review of English-language materials before sending them to a local regulatory affairs expert for local review and validation. Once local validation is complete, the local regulatory affairs expert sees that the promotional documents get sent to NCAs if required.

ProductLife Group specialises in helping international life sciences organisations more effectively get their products and therapies to market by providing those clients with functional support across all of the regulated stages of the product life cycle—from development to launch, to postmarketing.

Performing successfully for more than 25 years, ProductLife Group has an established global presence in Europe, the Middle East, Asia Pacific, Africa, Latin America, and North America. We deliver services via an innovative, platform-and-hub operating model, enabling our clients to achieve continuous improvement, increased quality, enhanced performance, reduced risk, better compliance, and overall cost benefit. That approach, combined with our collaborative, partnership-oriented culture, empowers life sciences organisations to realise the commercial potential of their own international operations.

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Promotional-material support at the local levelProductLife Group has a network of local affiliate offices and regulatory specialists to support the regulatory and legal review and validation of promotional and nonpromotional materials. A global project coordinator manages the governance and supervision of all local projects, including:

Strategic expertise for promotional materialsProductLife Group’s team of regulatory experts supports clients with strategic advice, consulting, and regulatory intelligence on promotional compliance regulations and guidelines, including the latest updates by regulatory authorities. In addition, our team offers insights into the codes and guidelines issued by such organisations as the European Federation of Pharmaceutical Industries and Associations and the Association of the British Pharmaceutical Industry, which developed a self-regulatory code that sets standards for the promotion of medicines to health-care professionals in the United Kingdom.

The team also supports clients by writing, reviewing, and revising the documents needed for overall quality management of promotional materials, including standard operating procedures, validation forms, and working instructions. And the team provides advice and support on the validation workflow through the recommendation, configuration, and implementation of software.

With extensive experience to draw on, ProductLife Group can provide training for all of a client’s departments that are involved in promotional-material review and validation. To ensure objectives get met, ProductLife Group also offers personalised key performance indicators, which are communicated at regular intervals.

The benefits of working with ProductLife GroupProductLife Group has a large and dedicated internal organisation focused on managing all promotional and legal compliance activities across multiple markets.

We provide a single point of contact at the central level, where our team of promotional-compliance experts manages all issues related to the review, sign-off, and submission of promotional documents to national competent authorities, as well as the coordination of local regulatory reviewers and, if required by the client, the management and archiving of the client’s internal tools of validation. Our unique hub structure gives us expertise at the global and local levels to support reviews based on international and local requirements.

Local evaluation and certification

of promotional and nonpromotional

materials

A quality check of artwork

and printed materials

Preparation and submission of promotional

campaign materials to NCAs when

required

Follow-up and interaction

with NCAs

Writing and updating of standard operating

procedures and working-practice

documents

Consulting on promotional

and legal compliance

topics