Areas of Expertise
Procedures and Process Improvement
This includes process analysis, mapping, Standard Operating Procedures (SOP) development, implementation and evaluation. If your organisation operates to GCP, GLP or ABPI Code, or has a Sales & Marketing function then you will already appreciate the crucial role of documented procedures in demonstrating, when challenged, your organisational and staff commitment to doing the right thing.
The UK Bribery Act raises the bar. Liability specifies failure to prevent bribery for which the only statutory defence is having adequate procedures in place.
STEP-IN Management has associates who specialise in writing procedures (SOPs) against regulation, law and Code. Our hallmark is brief, clear, pragmatic SOPs which reflect the reality of the workplace.
STEP-IN Management has considerable experience in designing and launching web-based SOP systems to make procedures accessible to users.
Sales & Marketing/ Commercial Compliance
In seeking to comply with ABPI and European codes for the marketing of prescription medicines, companies need sound, risk-based approaches, to embed business integrity and compliance into their commercial operations.
A commercial compliance programme will include Anti-Bribery and Corruption (ABC) and FCPA factored into Sales Force operations and Leadership mores
Increasingly it includes building compliance into digital marketing initiatives.
Any commercial compliance programme must address Data Privacy and Protection for customer, employee and patient data and may need to encompass Data Controller responsibilities and data privacy breach responses across Europe-wide or global projects
STEP-IN Management has a strong track record of establishing compliant but pragmatic operational procedures based on business risk assessment to replace SOP heavy, ‘safety net’, cultures.