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Services
As your development partner, we will provide your company with pharmaceutical development services that are responsive, personal, efficient, and strategically sound. Using our established network of expert consultants (e.g., experts in the fields of toxicology, clinical development, pharmacokinetics, pharmaceutics, analytical chemistry, etc.) we are able to offer your company a large, well-established organization of specialists with expertise in all areas of drug development.
Overall drug development and strategic planning
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.
» Reduce the cycle time
» Reduce the cycle time
Worldwide scientific regulatory strategies
Meet the complex regulatory environments that exist throughout the world.
» Accelerate the movement of new products to worldwide commercialization
» Accelerate the movement of new products to worldwide commercialization
Nonclinical and clinical research programs
Integrating nonclinical and clinical research programs facilitate rapid development time and accelerate the movement of new products to worldwide commercialization.
» Assure Good Laboratory Practice (GLP) compliance
» Assure Good Laboratory Practice (GLP) compliance
Chemistry, manufacturing and controls
Experience with complete formulation development programs, from the development phase to the production of clinical and commercial supplies for new chemical entities as well as generic compounds.
» Ensure the quality, consistency, and technical validity
» Ensure the quality, consistency, and technical validity
REMS Submission and Management
A Risk Evaluation and Mitigation Strategy (REMS) is a recent and emerging regulatory requirement whereby the FDA expects pharmaceutical and biotech companies to monitor, submit plans, and proactively manage safety risks as part of NDA submission and life-cycle management.
» Learn how Beckloff associates can help
» Learn how Beckloff associates can help
Compliance services
We have conducted numerous manufacturing, testing, and packaging facility audits and have assisted companies in attaining compliance with GMP regulations.
» Decrease development time and increase market years
» Decrease development time and increase market years
Regulatory Publishing Services
Beckloff Associates has over 30 years of experience in preparing, reviewing and publishing regulatory submissions.
» Ensure the quality, consistency, and technical validity
» Ensure the quality, consistency, and technical validity
eCTD
Beckloff Associates understands the Electronic Common Technical Document (eCTD), and is ready to help you unlock the full lifecycle value of electronic content and submission management.
» Preparation and submission of eCTDs and more
» Preparation and submission of eCTDs and more
Training and education
Our clients consider us an outstanding educational resource for worldwide drug development.
» Four representative workshops are provided
» Four representative workshops are provided
Post-Approval Maintenance Support
Our partnering model involves designating one or more of our highly experienced technical consultants as a dedicated resource to your organization.
» How does it work?
» How does it work?
Strategic Medical Writing Services
Beckloff Associates, Inc., can add value to your regulatory submissions by understanding and interpreting the strategic and scientific aspects of your development program.
» Learn more about the Beckloff Advantage
» Learn more about the Beckloff Advantage
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