New Market Regulatory Compliance
This US-based, performance-beauty company chose Practicus as its partner to help it establish new operations in the UK and Europe. It provides aesthetic products to physicians and part of establishing its presence in the UK and Europe was launching its latest products into those markets.
To do this, it required support to establish best practice regulatory and compliance operations and procedures in line with the APBI and EFPIA Ethical Codes. It also needed to roll out new CRM tools enabling greater transparency in analysing and interpreting data as it prepared for launch.
How we did it
Our team of Consultants:
- Performed a detailed review of medical compliance processes to establish compliance with APBI and EFPIA codes and created a new Standard Operating Procedure
- Created a library of APBI and EFPIA compliant training material for internal and external stakeholders
- Managed the accuracy of marketing material and compliance for engaging Healthcare Professionals, Patient Representative Organisations and Key Opinion Leaders aligning with best practice and ethical standards
- Managed product Final Sign Off, working closely with US Head Quarters and manufacturers in Korea
- Successfully rolled out CRM tools across UK and Europe for fit-for-purpose interpretive data analysis and tracking market engagement compliance
The overall outcome
The company successfully launched its new product in November with resounding success and positive feedback from the market, clinicians and patients. As a result of the work delivered, it was able to meet its obligations to ensure robust operating procedures were in place before the launch, and could bring its new product to market in line with its strategies.
The successful roll out of its new CRM tools allows the company visibility of its business intelligence data. This enables real-time analysis as regulatory and compliance standards change over short periods of time and allows for greater transparency over market engagement information.
Placements
- Regulatory & Compliance Consultant
- Compliance Consultant
- Marketing Consultant
- Final Signatory
- CRM/BI Consultant
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