Beckloff Associates, Inc.
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Beckloff Associates, Inc.?
Overview
As your development partner, we will provide your company with pharmaceutical development and regulatory affairs services that are responsive, personal, efficient, and strategically sound. Using our in-house staff and 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.
Standards & Methodologies
Nonclinical project management Preparation of nonclinical development plans Development and review of nonclinical study designs and protocols Liaison activities with regulatory authorities Integration of nonclinical and clinical programs Selection, qualification, management, and monitoring of nonclinical study sites Good Laboratory Practices (GLP) audits Preparation and evaluation of nonclinical reports Preparation of non-clinical sections for INDs and NDAs Clinical program and management Preparation of clinical development plans and study designs Specialized research studies Network of clinical expert consultants Coordination of team of experts Liaison activities with regulatory authorities Clinical supply management, including labeling and packaging Selection, qualification, management, and monitoring of bioanalytical laboratory, Clinical Research Organization (CRO), clinical trial sites and investigators Good Clinical Practices (GCP) Audits Medical writing Preparation and quality assurance of protocols, case report forms, informed consent forms, Investigator's Brochure, Final Study Reports, Expedited IND, and Postmarket Safety Reports Preparation of clinical sections for INDs and NDAs
Qualifications, Certifications, Accreditations & Licenses
Nonclinical project management Preparation of nonclinical development plans Development and review of nonclinical study designs and protocols Liaison activities with regulatory authorities Integration of nonclinical and clinical programs Selection, qualification, management, and monitoring of nonclinical study sites Good Laboratory Practices (GLP) audits Preparation and evaluation of nonclinical reports Preparation of non-clinical sections for INDs and NDAs Clinical program and management Preparation of clinical development plans and study designs Specialized research studies Network of clinical expert consultants Coordination of team of experts Liaison activities with regulatory authorities Clinical supply management, including labeling and packaging Selection, qualification, management, and monitoring of bioanalytical laboratory, Clinical Research Organization (CRO), clinical trial sites and investigators Good Clinical Practices (GCP) Audits Medical writing Preparation and quality assurance of protocols, case report forms, informed consent forms, Investigator's Brochure, Final Study Reports, Expedited IND, and Postmarket Safety Reports Preparation of clinical sections for INDs and NDAs
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Industries Served
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Testing Types
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