Companies in the Life Sciences industry, such as medical device manufacturers, pharmaceutical companies, and biotech companies serve a higher purpose than most commercial endeavors. These industries are heavily regulated by national and international governments and agencies such as the US Food and Drug Administration and the European Medicines Agency.
One small oversight or mistake can have exponentially negative ramifications. It can be the undoing of your brand’s good reputation or even of its ability to remain solvent. You live under the constant threat of government fines, remediation costs, product recalls, and consumer or class action lawsuits, just to name a few.
So just how do you find opportunities for growth while remaining within the constraints of your compliance commitments?
BDM Squared is a Project Management firm with deep experience in the life sciences vertical. From our consultant’s extensive know-how, we’ve deduced these top four simple, yet powerful strategies that have proven themselves to be the best offensive measure to take because they provide the greatest protection against risks.
Strategy #1 – Establish operational methodologies designed to mitigate risks.
Whether your company is relatively new or has a rich history of innovation, it is critical that your operational protocols are designed to exceed regulatory requirements. Even if you must invest the resources to bring older projects up to standard, in the end, it will be money well invested. Part of this plan should include regularly training your staff on procedures and software usage for the benefit of new hires and also because the regulations landscape can change annually.
Strategy #2 – Your IT and Software solutions should service your risk compliance needs.
The right technology can dramatically improve your results. Using software systems designed for your industry will help you maximize your return on investment. Your software suite should definitely help you keep track of your QA concerns, among other key business issues. Be sure your IT team continuously updates your network security protocols to protect your proprietary data.
Strategy #3 – Design a crisis management plan.
Hopefully you will never need to enact your crisis management plan. But deciding ahead of time what options you might potentially take in the face of anticipated “worse case scenarios” will help you and your team spring into appropriate actions, if ever disaster strikes. Your plan could include having a team of specialized lawyers at the ready, designated funds for unexpected fines or fees, having a 12-month cashflow plan, a remote work plan for employees, and more.
Strategy #4 – Partner with Consultants or Project Managers who are experienced compliance experts.
Compliance projects and emergency projects such as remediation or working through a recall can easily overwhelm your staff who may need to still perform their regular duties on top of the special project. Partnering with specialized consultants will relieve your team member’s stress. Your chosen consultants likely have a depth and breadth of experience your internal team members may not have. You will be gaining experts who have likely worked with other companies in your field. They can provide current perspectives and insight as you are formulating and executing new strategies and initiatives.
Pharmaceutical and other medically related companies must successfully address the intersection of FDA regulations with public safety concerns in order to establish and maintain their solid growth trajectory. BDM Squared’s Life Sciences consultative and project management services can ensure that a wide variety of projects in your business meets or exceeds your goals. More specifically, we can help with:
- Management of regulatory projects
- Research Compliance and Administration
- Compliance Training
- Functional and Technical Project Compliance
- International Research Project Support Services
- Computer System Validation (CSV)
- Vendor Risk Management
- Quality System Development
- 21 CFR Part 11
Risk mitigation projects and remaining in compliance flows better when you work with a partner who is well versed in your industry. Let BDM Squared bring our experiences working with other companies in the life sciences to guide your next strategic initiative.
Are you unsure if you are properly safeguarded against major blows to your brand’s image or major hits to your bottom line? We can perform a Project Health Assessment. We will examine a project that is getting ready for market or assess your company’s compliance gaps as a whole. We will also assess the methodologies your team is utilizing and will rate their performance against it. The detailed analysis we provide will give you the insights you need to make critical decisions.
Whether you need our assistance over the short or long term, our Life Sciences consultants and Project Managers are ready to apply our proprietary and best project management practices on your behalf.
Beyond compliance and regulatory projects, at BDM Squared, we can also provide companies in the life sciences assistance with their brand recognition, procuring financial support, corporate license, and medical communications. Put our wealth of experiences in the life sciences to work in your company and experience the difference!
Give us a call at 404-301-5879 or send an email to [email protected] to schedule your consultation.