Planning for business continuity in the pharmaceutical and biotech industries is a unique and challenging process. Supply chain complexities (single and sole sourced relationships caused by the need for validated products and processes), CGMP manufacturing, product handling and transportation, general regulatory compliance (including FDA 21 CFR 11), product recall, research and development, clinical trials, adverse events reporting, security and facilities management – let alone the supporting technology – are all unique and the loss of any of these processes or infrastructure elements can result in significant impacts.

While the industry has always been on the cutting edge of minimizing inventory to optimize returns, this practice creates significant business continuity risks. Additionally, the time needed to restore many biotech processes is months, even years, as regulatory approvals are needed to validate production processes.

These unique challenges demand an approach which balances reducing the likelihood of a disaster and limiting the impact. Often, building resilient production lines is the best approach to continuity planning in this industry, although it doesn’t negate the need to have crisis management, crisis communications, business resumption and IT disaster recovery solutions in place to minimize downtime.

Our organization has the skills and experience to lead, facilitate and/or participate in this process. We have experience serving large pharmaceutical and biotech organizations.