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Overall drug development and strategic planning
Beckloff Associates has been successful in achieving our clients' goals by developing and implementing efficient scientific regulatory strategies early to reduce the overall product development time and research investments, while maximizing the market years and thereby increasing the return on research investment.
We have earned our clients' trust and have been the development partner of companies worldwide. Through our network of recognized consultants and experienced professionals, we have become one of the leaders in successfully navigating the maze of government regulations. The result of our efforts is an increase in the financial return on the research investment of our clients.
To reduce the cycle time typically required to attain worldwide product approval, we provide strategic planning and product development services such as:
Scientific and Regulatory Strategies
- Regulatory guidance and management in all phases of product development and regulatory submissions
- Development and coordination of worldwide objectives
- Product feasibility research and analysis
- Guidance for responses to warning letters, inspections, clinical events, etc.
- Guidance on orphan drug designations
- Guidance on fast track designations
- Information research and expert opinion reports
- Liaison activities with regulatory agencies
- Organization of, preparation for, and participation in meetings with regulatory authorities
- Access to a broad network of specialized regulatory experts
Product Development Planning
- Development of program outlines
- Preparation of product development timelines
- Product cost-reduction analysis and management
- Selection and management of product development contractors, including analytical, bioanalytical, formulation, process development, manufacturing, labeling, packaging, and quality control
- Guidance on and execution of technology transfer
- CGMP, GLP, and GCP audits and PAI readiness programs
- Access to a broad network of specialized development experts
For capabilities that will meet your needs, and outcomes that will exceed your expectations, partner with Beckloff Associates today. For more information, fill out our Contact us form or call a member of our sales staff at 913.451.3955.
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