Regulated Sales and Marketing Processes

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Business & Decision Life Sciences specializes in the implementation and validation of regulatory significant applications within the life sciences sales and marketing area, including complaints management, adverse events reporting, product recall, service management, patient and donor management systems.

Depending upon the drug profile or medical device classification, field sales, service or call center processes within the pharmaceutical, biotechnology, biomedical or medical device sectors may have a regulatory impact and may require appropriate validation. In most cases advertising, promotional and other marketing activities must comply with regulations usually defined at the country or state level.

While customer call centers for over-the-counter medicines may have a minimum of regulation, customer complaints must be managed appropriately and may require classification as the first step in an adverse event management process. Call center systems may also be used to support product recalls. In some cases medical representatives capture regulatory significant information such as patient tracking to serialized devices, marketing spend and sample management and many service requests for medical devices also fall within the scope of quality system regulations.

There is also a growing tendency to use the rich functionality of CRM systems to support patient and donor management with corresponding requirements to protect personally identifiable health information and validate certain processes such as donor recruitment and donor management.

Although critical to patient safety, these are a minority of the processes within the sales and marketing domain and although linked to manufacturing and supply chain quality systems, the cost effective validation of supporting systems remains a challenge.

Regulatory Significant Process and Solutions

Incorporating appropriate customer analytics, regulated field sales, service and call center solutions for the life sciences industry are based upon industry leading solutions from our software partners, and include:

  • Complaints management
  • Adverse Events Reporting (AERS)
  • Product recall
  • Donor management
  • Patient management
  • Service management
  • Pharmacovigilance
  • Device tracking

In many cases, a subset of processes or interfaces to other quality systems may require appropriate risk-based validation. Business & Decision Life Sciences supports clients to analyse their requirements, determine the regulatory significance of their business processes by customer segment, product and geography and are then able to cost effectively implement and validate such systems on the basis of a risk-based approach to validation.

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