HEALTHCARE LIFE SCIENCES

  Engage our consultative approach to quickly identify solutions that reduce costs, accelerate approval timelines and improve your processes. Ranging from preapproval to post-approval, and from intellectual property to FDA approval, we strategized cost-effective, high-quality regulatory affairs solutions for lifecycle maintenance of your pharmaceutical products.  

 If your organization is in the pharmaceutical, biotech, consumer health, animal health or medical device space, partner with us for consultation that streamlines your end-to-end drug safety surveillance activities for investigational and post-market products. Our drug safety and risk management solutions allow you to focus on managing your core business, while we create a strategy that supports patient safety and protects your company. Access the resources you need to ensure timely submission of quality adverse event data to various regulatory authorities.  

 Create a long-term plan that ensures the production of quality products while meeting compliance requirements. Capitalize on our extensive experience in pharmaceuticals, biotechnology and medical device industries for comprehensive validation solutions. Ensure that you meet and maintain worldwide regulatory requirements, access cost-effective and efficient equipment qualification and validation services, and quickly evaluate, test and determine the appropriate cleaning process to meet your validation needs.  

 Develop solutions that increase efficiencies, productivity, and quality in your clinical trial from study start-up through completion. By strategizing for the level of support you need, we create clinical operations solutions to facilitate all aspects of your clinical trial — including management of staff and training, budgets and contracts, patient recruitment and retention, and site operations — to drive on-time project delivery.  

 Create a long-term plan that ensures the production of quality products while meeting compliance requirements. Specializing in corrective and preventive action, we develop solutions that address your quality and regulatory compliance processes. Protect your business and increase your efficiency by leveraging our strategy to manage systems implementations, process improvement, audits and remediation of problems.