Welcome to TBD BioPharma
TBD BioPharma is a pharmaceutical regulatory consulting firm coupled with an innovative analytical development laboratory. With a profound understanding of global pharmaceutical regulations and a commitment to excellence in product development and analytical sciences, we assist pharmaceutical companies worldwide in navigating the complex landscape of regulatory compliance and product development.
Mission Statement:
At TBD BioPharma, our mission is to empower pharmaceutical companies to bring safe, effective, and high-quality drugs to the market and to patients efficiently. We achieve this by providing unparalleled regulatory guidance and cutting-edge analytical services tailored to meet the unique needs of each client.
Services
Regulatory Consulting:
FDA & EMA Compliance: Expert guidance on regulatory requirements set forth by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
Drug Development Strategy: Strategic planning and regulatory support throughout the drug development lifecycle, from preclinical to post-marketing phases.
Quality Assurance & GMP Compliance: Assistance in establishing and maintaining Good Manufacturing Practice (GMP) standards to ensure product quality and compliance.
Regulatory Submissions: Preparation, review, and submission of regulatory documents, including Investigational New Drug (IND) applications, New Drug Applications (NDAs), and Marketing Authorization Applications (MAAs).
Analytical Development Laboratory:
Method Development & verification: Development and verification of analytical methods for drug substance characterization, impurity profiling, and stability testing.
Formulation Development Support: Formulation optimization and compatibility studies to enhance drug product stability and bioavailability.
Core Values
Patient Focus: At the heart of our culture lies an unwavering commitment to patient focus, driving every aspect of our research, development, and service to ensure the well-being and satisfaction of those we serve.
Expertise: Our team comprises seasoned regulatory professionals and analytical scientists with extensive industry experience and expertise.
Integrity: We uphold the highest standards of integrity, transparency, and ethical conduct in all our interactions and operations.
Collaboration: We foster collaborative partnerships with our clients, working closely with them to achieve mutual success and shared goals.
Excellence: We are committed to excellence in everything we do, striving for continuous improvement and exceeding client expectations.
Clientele
TBD BioPharma serves a diverse clientele, including pharmaceutical manufacturers, biotechnology companies, and contract research organizations (CROs).
At TBD BioPharma, we are dedicated to being your trusted partner in regulatory compliance and analytical excellence. Let us navigate the complexities of pharmaceutical regulations and development challenges, so you can focus on what matters most – advancing healthcare through innovative drug development.
We strive to bring your vision to life. Let's embark on this journey together and create something extraordinary.
Share your story, dreams, and aspirations with us. We are here to listen, guide, and support you every step of the way.
Your success is our success. Let's make magic happen!
