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.

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Services

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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. Learn more

Compliance services

We have conducted numerous manufacturing, testing, and packaging facility audits and have assisted companies in attaining compliance with GMP regulations.

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Worldwide scientific regulatory strategies

Meet the complex regulatory environments that exist throughout the world. Learn more

Regulatory Publishing Services

Beckloff Associates has over 30 years of experience in preparing, reviewing and publishing regulatory submissions.

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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.

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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. Learn more

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.

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Training and education

Our clients consider us an outstanding educational resource for worldwide drug development.

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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.

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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.

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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.

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State Licensing services

State Licensing for drug products and devices is required by most states and needs to be in place prior to distribution of products to that state. Beckloff Associates, through its experienced staff and management systems, can support all your state licensing needs.

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