Corporate Brochure
Regulatory Affairs
The Regulatory Affairs section provides a comprehensive suite of resources designed to support your regulatory needs. From Regulatory Agency Representation, offering expert guidance and advocacy with regulatory bodies, to Regulatory Strategy Development, which ensures your products meet all necessary compliance requirements. This section also includes resources on the Management and Preparation of Regulatory Submissions, providing detailed assistance in compiling and submitting regulatory documents. Additionally, there are guides on Responses to Regulatory Challenges, helping you navigate and address any issues that arise during the regulatory process. For those involved in innovative therapies, the Breakthrough Therapy Designation Requests resource outlines the steps to expedite the development and review of drugs that treat serious conditions. Lastly, the Cellular and Gene Product Programs resource provides specialized information for the regulation of advanced therapeutic products. Each resource can be easily downloaded by clicking the respective links.
CMC
The CMC (Chemistry, Manufacturing, and Controls) section is equally robust, featuring resources such as Materials Characterization and Formulation Development, which aids in understanding and developing materials for pharmaceutical products. Process Development, Optimization, and Validation resources help streamline and validate manufacturing processes. The Analytical Method Development, Optimization, and Validation guide offers insights into creating and perfecting analytical methods, while Stability Program Design and Management focuses on ensuring product stability throughout its shelf life. Resources on Vendor and Contractor Identification and Management assist in selecting and managing external partners, and the Supply Chain Assessment and Management resource ensures efficient and compliant supply chain operations. Finally, CMC Regulatory Affairs Support provides specialized regulatory guidance for CMC-related issues. Each of these resources is available for download via the provided links.
QA
The QA (Quality Assurance) section provides essential resources designed to uphold and enhance quality standards within your organization. Quality Assurance Services offers comprehensive support to ensure your processes and products meet regulatory and quality requirements. The Design, Implementation, and Remediation of Quality Systems resource guides you through creating robust quality systems, as well as addressing and correcting any deficiencies. For ensuring the readiness and reliability of your vendors, Vendor Qualification, Inspections, and Mock Pre-approval Audits provides detailed protocols and practices. Finally, Management of Compliance Situations delivers strategies and solutions for effectively handling compliance issues as they arise. Each resource can be downloaded by clicking the respective links.
Expedited Drug Delivery
The Expedited Drug Delivery section provides a curated collection of resources to accelerate your drug development process. The Resource Library houses essential guides, starting with Process and Formulation Development Considerations, which offers insights into optimizing drug formulation and processing. Manufacturing Scale and Launch Site Considerations ensures you are prepared for scaling up production and selecting appropriate launch sites. Process Validation Considerations provides key protocols for validating your manufacturing processes, while Analytical Development Considerations focuses on developing and refining analytical methods.
The section also includes Control Strategy Considerations, which outlines strategies for maintaining control over your manufacturing process, and Stability Data Considerations, which offers guidance on ensuring product stability throughout its lifecycle. Additionally, Quality System Alignment with BT Product Development Considerations ensures your quality systems are in line with breakthrough therapy product development requirements.
For a comprehensive overview, you can also Download our Expedited Drug Development eBOOK. Each resource can be easily downloaded by clicking the respective links.
Whitepapers
The Whitepapers section offers a rich selection of in-depth resources to enhance your understanding and management of drug development processes. The featured whitepaper, What It Means To Be “Breakthrough”: Expediting Drug Development—the New FDA Breakthrough Therapy Designation, provides insights into the advantages and requirements of the FDA's Breakthrough Therapy designation.
Within the Resource Library, several key whitepapers cover critical topics. Pharmaceutical Stability delves into methods for ensuring the stability of pharmaceutical products, while How ICH Is Changing Drug Development explores the impact of International Council for Harmonisation guidelines on drug development. Know Your Process Limits offers guidance on understanding and managing the limitations of your manufacturing processes. Practical SOP; Lower Cost of Goods presents strategies for developing practical Standard Operating Procedures to reduce costs. Timing Method Validation provides insights into the optimal timing for validating analytical methods. Top Five Reasons for CMC Clinical Holds identifies common reasons for clinical holds related to Chemistry, Manufacturing, and Controls (CMC) and how to avoid them. Translating QbD Guidance into Development Objectives discusses how to apply Quality by Design principles to your development objectives. Managing Phase 2 CMC Risk offers strategies for mitigating risks during Phase 2 of clinical development. Virtual Quality Assurance: Sponsor Responsibilities outlines the responsibilities of sponsors in maintaining quality assurance in a virtual environment.
Each whitepaper in the Resource Library is available for download, providing valuable insights and practical guidance for advancing your drug development projects.
