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Cardinal Health Specialty Solutions Scientific and Regulatory Consulting

Description: 

Beckloff Associates, a Cardinal Health company, is a full-service pharmaceutical research and development consulting firm that specializes in helping pharmaceutical, biotechnology, and medical device companies obtain timely and comprehensive regulatory approval. Our industry-leading scientific and regulatory strategies and tactics serve your product from the laboratory bend to the pharmacy self...and our expertise and influence extend from the U.S. market to the Canadian and European markets.

 

Since 1976, we have provided solutions that effectively minimize development time – and thereby maximize available market years and revenue for your pharmaceutical product, biologic or medical device. Our goal is to help you increase the financial return on your research investment by offering a comprehensive consulting platform that includes:

 

o Strategic drug development and worldwide regulatory strategies

o Nonclinical development consulting

o Clinical development consulting

o Medical Writing

o Chemistry, manufacturing and controls consulting

o Preparation of regulatory documents for drugs and devices

o Risk Evaluation and Mitigation Strategies (REMS) strategy, preparation, implantation and management

o Post-approval regulatory and submission support

o Advertising and Promotional Labeling Review (DDMAC)

o Regulatory publishing services (paper and electronic, CTD format)

o CGMP, GLP and GCP compliance services

o State Licensing services (preparation and maintenance)

o Customized training programs

 

As your development partner, we will provide your company with pharmaceutical development 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.

 

Scientific Regulatory Affairs and Documentation

 

Liaison to Regulatory Authorities

Interactions with the Regulatory Authorities regarding project-specific issues or current position on certain issues

Interactions with the Regulatory Authorities to coordinate current Good Manufacturing Practices (CGMP), Good Laboratory Practices (GLP), and Good Clinical Practices (GCP) FDA inspections, including follow-up correspondence and documentation

Meetings with Regulatory Authorities regarding drug development programs (i.e., pre-IND,

end-of-Phase 2, pre-NDA, and Advisory Committee meetings), including meeting organization, information package preparation, and meeting management

Regulatory guidance at all stages of product development

Drug Master File (U.S. DMF, ASMF, CDMF) preparation and maintenance

Chemistry, Manufacturing, and Control (CMC) documentation preparation for Drug Substances and Finished Formulations (IND, NDA, ANDA, BLA, NADA, NDS)

Nonclinical and Clinical documentation preparation and review for:

§ Investigational New Drug Application (IND), Amendments, Safety Reporting, and Annual Reports

§ New Drug Application (NDA), Amendments, and Supplement Annual Reports, and Postmarketing Reporting

§ Biologics License Application (BLA) preparation and maintenance

§ 505(b)(2) NDA Application, Amendments, Annual Reports, and Postmarketing Reporting

European and Canadian submission support (IMPD, CTA,MAA,NDS,CEP)

Regulatory Publishing support (paper and electronic, CTD format)

Services: 

Chemistry/Manufacturing/Controls, Clinical Trial Design, Comprehensive Drug and Biologic Development, Electronic Submissions Preparation, GCP Compliance, GLP Compliance, GMP Compliance, Medical Writing, Regulatory Affairs/Regulatory Strategy, Regulatory Document Preparation

Contact Information: 

Cardinal Health Specialty Solutions Scientific and Regulatory Consulting
7400 W. 110th St., Suite 300
Overland Park, KS, 66210, USA
Phone : 9134513955
Fax : 9134513846
Internet : www.cardinalhealth.com/us/en/specialtysolutions
Email : info@beckloff.com
Contact Person : Christopher Kavlick