Quality Systems Design, Strategy, and Implementation
With the capacity to handle any level of project, we integrate seamlessly with your team so you can respond quickly and accurately to your business challenges without giving up control.
With deep expertise in health authority regulations and guidance, we partner with you on all aspects of quality systems development. The cornerstone of any quality improvement program is sustainability – we understand that remediation exercises are only meaningful if they result in lasting quality system improvements. Our programs engage your management team to assure the proper control processes are in place long after your project is complete.
Health Authority Enforcement Action Response and Remediation
Whether you’re shoring up the quality management system of one facility or need a corporate-wide response to a warning letter, we’ll rapidly deploy the right-sized solution team for your unique needs. Our network of former quality and operations executives have been where you are and they understand the nuances of working with regulatory agencies. Our approach doesn’t just address your compliance concerns – it keeps your business objectives front and center during the process.
Inspection Readiness and Support
You’re creating the future of healthcare, and part of that challenge is navigating the periodic inspections that come with innovating an industry. Our network is comprised of industry operators and former-FDA experts that know how to prepare your company for a successful inspection event.
Quality Systems Auditing and Assessment
We partner with you to assess your quality systems and processes, and continue working with you to implement the best solutions for your business objectives. We work with companies who’ve entered into a Consent Decree with the FDA to provide necessary third-party reporting about progress against improvement commitments. We also assist companies looking to expand their portfolios through merger and acquisition by providing targeted and responsive assessments that surface a comprehensive picture of any quality and regulatory risks that may affect these important decisions.
Quality Operations Support
We offer you a unique portfolio of expertise in the quality compliance discipline, including strategic support, technical expertise, and project-based solutions. We bring our resources to your team quickly, so you can meet any unexpected validation and requirement issues without derailing your day-to-day operations. Whether in support of marketing claims or in response to enforcement actions, our experts help you strategize and execute the process of post-market vigilance. We’ll help develop your program, author validation master plans, write your protocols, execute testing, write reports, and provide Quality oversight. Everything we do is in partnership with you, and tailored to your unique needs
and business objectives.
Laboratory Controls / Data Integrity Assessment
Data Integrity has taken on a new position of importance in recent years, prompting the FDA to issue new guidance for biopharma firms to follow and putting many companies in an urgent compliance situation. We quickly field expert resources to evaluate your firm’s compliance and design a remediation approach to execute against right away. Our laboratory experts can assess your operations to help assure that your processes and procedures protect you.
DataRevive Regulatory Services
DataRevive is a leading Regulatory Affairs consulting firm helping pharmaceutical and biotech companies with their regulatory filing of US IND, BLA, and NDA during drug development. DataRevive specializes in both small molecule and biologic product regulatory affairs. They have expertise in CMC (chemistry, manufacturing, controls), nonclinical, clinical pharmacology and clinical areas. Their lead consultants have worked in FDA or industry for more than 18 years with extensive experience in drug discovery and development. For further information, please visit http://www.data-revive.com.
Global Regulatory Strategy and Operations
With an unparalleled track record and global reach, we’ve put our regulatory expertise to work for leading pharmaceutical, medical device, and biotechnology firms. Our unique end-to-end approach means our service is customized to your business situation – and our robust network of regulatory experts and specialists are deployed on demand. We act quickly and effectively for both preemptive compliance and expedited crisis management. Our goal is aligned with your objective: to assure safe and reliable access to the world’s life-saving healthcare products.
Interim Executive Leadership
Your Quality or Regulatory leader recently left and there’s no ready successor. While you recruit for the longer term, we’ll provide an interim leader who can keep the organization moving forward, leading the staff and representing the organization to management. Our experienced interim leaders understand how to plug into your company, strategize in support of your business objectives, and work within your culture to assure minimal disruption.