The Problem: Biotechnology Manufacturers are faced with significant challenges in moving their products through an extreme and complex FDA/EMA drug approval process or obtaining international regulatory compliance. Because this is an upcoming industry, regulatory bodies cannot manage over 1500 biotech manufacturers in the U.S. who are or will be seeking these approvals. What we've experienced is many of these manufacturers are struggling trying to do the right thing without the proper Chemistry, Manufacturing and Control (CMC) and Investigational New Drug (IND) or ISO guidance to accurately submit these complex requirements. Over the past 10 years, we've learned that most of these regulatory entities have limited resources to implement the planning it takes to qualify products that can potentially help our patients in need. Our "Bridging the gap between biotech manufacturing and Regulatory Affairs" services include comprehensive, end-to-end process support, and quality management for your CMC/IND and ISO compliance efforts so you can focus on the drug discovery, development and manufacture in advancing the field of biologic medicine and therapies. That's how we ensure your success.
Our Services: We offer comprehensive end-to-end process support for your CMC efforts–from early development and optimization endeavors, to progressing through scale-up during advanced development, to supporting your end commercial process. Consider us your trusted CMC partner throughout the entire process. Our consultants each have an average of more than 20 years of experience in the Pharma industry, from Development, Operations, Technical Services, Quality Assurance, Quality Control, Compliance, and Auditing. We provide expertise in formulation and design, process optimization, scale-up, technical transfer, CDMO selection/management, technical design, fill/finish, and protocol review, and our experience spans API, Drug Substance, and Drug Product activities.
Our team seamlessly integrates our resources with your team, so you can address technical hurdles or compliance obligations without undermining normal operations. We support the authoring of various key documents, including policies and procedures, validation master plans, technical protocols, oversight of sampling and testing programs, authoring final technical and stability reports, and providing Quality Systems expertise oversight, among other tasks.
Our CMC Consulting Services include:
Moving products into clinical development is a key milestone that not only creates organizational value, but, more importantly, advances them closer towards commercialization, where they can serve the patients who need them the most. Once in the clinic, progressing through clinical trials is a complex endeavor that requires proper medical/scientific proficiency as well as operational and programmatic expertise to execute studies in a compliant and efficient manner.
Our consultants can support your clinical research efforts by providing the relevant subject matter expertise to effectively implement and execute your clinical programs. From assisting with early planning during preclinical development, to supporting regulatory agency engagement, managing your CROs and supporting your regulatory submissions, we work with you every step of the way. In addition, we have subject matter expertise in other product development functional disciplines (CMC, Regulatory, Quality, etc.) that can be leveraged to ensure that a comprehensive approach is taken with regard to your clinical development programs.
Our Clinical Development/Operations Consulting services include:
Total Quality Management (TQM) is an essential part of the biological life science product development process. Manufacturers and Laboratories need to ensure that their products are safe and compliant with all quality standards and regulations set by local and/or international bodies. We have extensive hands-on experience in ensuring ISO, and CLIA/CAP compliance within the biologic pharmaceutical and manufacturing industries. This includes specific expertise that spans to medical devices, cell and gene therapies and other industry compliance, among other areas.
We provide a wide range of services, including Quality Systems development and implementation, Quality Operations oversight, inspection management, PAI and audit readiness, development of KQIs, and Continuous Quality Improvement methodologies. In addition, we have experience working with various FDA Compliance Officers, State Public Health examiners, State/National ISO Accreditors and Malcolm Baldrige National Quality Award Examiners and International Ministries and Boards of Health.
As highly focused Global Quality professionals, we are committed to working with your team to create and maintain the highest possible quality standards. Our Quality team possesses a wealth of technical expertise consistent with global regulations and industry expectations.
Our Quality Services include:
For more information about how we can support your , please set up a meeting with Jeff Roth at jeffroth@tlstrategy.com.
Our AI GenMedReg ramp up process is designed to empower your team and outfit them with the tools they need to succeed in the Regulatory environment. Talk to us today about how we can support your growth, limit your turnover, and put you on a solid track to approvals and success.
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