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Beckloff Associates, consulting services to obtain approval for drugs, biologics and medical devices Services that are responsive, personal, efficient, and strategically sound

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Contact us online or at 913.451.3955.

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


Preclinical 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

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

Current Good Manufacturing Practices (CGMPs)

We have conducted numerous manufacturing, testing, and packaging facility audits and have assisted companies in attaining compliance with CGMP regulations.
» Decrease development time and increase market years

Regulatory Publishing Services

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

eCTD

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

Training and education

Our clients consider us an outstanding educational resource for worldwide drug development.
» Four representative workshops are provided