IBTSolutions utilizes considerable global reach to bring pharmaceutical products to market. Over 15 years of assisting in the growth of biotech and pharma companies through lead development, supplier management, and clinical trial engagement have led to a series of successes proving that IBTSolutions is a leader in the field of biosciences.
Offering customized solutions to meet the needs of our clients, IBTSolutions provides a service tailored to your product, and your specific needs. A driving force in the world of pharmaceutical development, IBTSolutions will utilize our peerless industry experience to bring your pharmaceutical advancement through regulatory roadblocks and into the market.
What we do
IBTSolutions provides in-depth consultation services for growing pharmaceutical and biotech firms during the preclinical and clinical stages of development. Drawing on years of experience in the industry, IBTSolutions will assist in bringing your product through each development stage as quickly as possible, while maintaining all regulatory requirements.
Having global reach means global experience, and IBTSolutions has experience with US, European and global markets and products. Capable of coordinating with external resources, IBTSolutions draws on a global system of pharmaceutical experts and manufacturers to meet the needs of our clients.
Our Team
Our team utilizes our diverse backgrounds in both the pharmaceutical and biotech industries, as well as working with regulatory agencies such as the FDA, EMA and DEA to offer clients a multi-faceted consultation with achievable action items to motivate expediency through the regulatory approval process. With decades of experience before joining IBTSolutions, each member of the team contributes a vital element to our success.
Testimonials
"IBTS brought a team of professionals to the table, each with specific expertise, which supported and complemented our internal team. They provided an unbiased, external perspective when it came to reviewing systems, documentation, and providing guidance as part of an overall Gap Assessment to determine if we were ready for Agency inspection, product approval, and subsequent launch. This Gap Assessment highlighted areas of concern, and provided us with an opportunity to prioritize, and to focus our internal and external resources on addressing those key issues identified, to ensure success."
"Excellent work by knowledgeable experts. A valuable resource to our team to help manage, navigate and conduct critical studies on time and on budget."
"I was fortunate to work with IBTS in a small company environment. The company progressed to a stage at which an overall assessment of readiness to file for marketing authorization was the key activity. IBTS was contracted to conduct a GAP assessment for Quality/Manufacturing, develop a remediation plan and lead its execution with the corresponding contract manufacturer. I was impressed by the combination of technical and managerial expertise. The GAP assessment identified the key issues, as confirmed by third parties later. The remediation plan was developed and executed, overcoming challenges of distance and culture. I would contract this group again any time for similar or related challenges."
