While it’s well known that having good compliance processes has become a vital part of business across all industries, just what this means exactly is far less clear cut. With varying degrees of obligations and a wide range of requirements depending on the individual business, even simply defining your compliance needs can often seem like an insurmountable task.
The complexities of these compliance needs are no more apparent than for those operating in, or with, the Life Sciences Industry. The sector is shaped by a robust combination of regulations, guidelines and industry standards that influence every area of the business. The result? A minefield of compliance requirements for both Life Science organisations and their SaaS providers.
For Life Science Organisations
Regulatory bodies such as the FDA and EMA, along with their respective guidelines and regulations, shape the industry in which these Life Science companies operate. For many of these organisations, compliance obligations are not only a prerequisite to operating in the industry but are often directly linked to the critical processes involved in patient safety. The difficulty can often lie in navigating this regulatory landscape. It can be complex, time-consuming and a huge drain on resources. This can ultimately hinder the Life Science organisation’s ability to maximise their operations by drawing focus away from their core business. Having efficient and effective quality and compliance processes in place, however, is a fundamental and unavoidable part of their business success.
For SaaS Organisations
SaaS companies trying to sell to Life Sciences customers also face compliance obstacles thrown up by this regulated market. The responsibilities might be slightly different but the lack of adequate compliance processes in place can have a similar negative impact on the business. Lack of a demonstrable compliance structure can often make or break those initial sales conversations. From security questionnaires to your understanding of Life Science industry regulations, compliance is often a stumbling block for SaaS companies trying to get a foothold in this highly competitive market. Without the necessary expertise or available resources in-house, organisations can struggle to get the correct compliance measures in place.
Whether you are a Life Sciences company or their SaaS provider, compliance can be a costly headache and it can be difficult to know where to start; what are the initial steps you need to take to assess your compliance baseline? How do you go about creating a compliance strategy that’s tailored to your needs? Do you have the right resources and expertise to achieve and maintain compliance into the future?
Odyssey VC can help. As a centre of excellence for compliance, we’ve created a framework for your compliance needs, specifically designed to eliminate confusion and allow SaaS and Life Sciences companies both to focus on what they do best – delivering great products. Our latest infographic takes you through our Compliance as-a-Service (CaaS) framework and offers a step-by-step solution for your compliance headaches.
Our latest infographic details the six stages that companies can choose to engage with us on and breaks down, step-by-step, how Odyssey can help you on your compliance journey. From supporting you in identifying applicable compliance regulations to controlling and maintaining your compliance into the future, you can choose your own entry point into our CaaS framework and tailor your compliance solution based on your company’s unique needs.
Odyssey VC have helped some of the world’s leading Life Sciences organisations grow and excel through their ability to meet regulatory requirements with minimal business interruption, and we have helped SaaS companies grow their business within Life Sciences and beyond by meeting the requirements of their target customers, giving them a unique advantage in the market.
If you would like to find out more about this or any other services we provide, get in touch and speak to one of our experts today.