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Pharmaceutical Development Group Inc

Description: 

PDG was founded in 1999 by Dr. Cheryl Blume and has quickly become a leading regulatory consultant to the pharmaceutical industry. Headquartered in Tampa, Florida, PDG is a recognized leader in providing a wide variety of pharmaceutical consulting services to organizations of all sizes, both international and domestic. PDG assists pharmaceutical firms in the navigation of the U.S. FDA submission and approval procedures for all products regulated by FDA.

PDG consists of a multidisciplinary team of scientists whose mission is to provide professional product development consulting services and the development of winning regulatory strategies for the pharmaceutical industry. PDG's competencies include pharmaceutical development across the spectrum of prescription, OTC, generic, and innovator drug products, biologic products, and medical devices.

PDG's experience includes the design, execution and oversight of all facets of product development, including strategic design of regulatory programs, all phases of clinical studies (Phases I-IV), non-clinical programs, formulation and CMC related assignments, manufacturing practices and statistical assignments. PDG's regulatory submission expertise includes but is not limited to:

o Development and Coordination of Pre-filing Meeting Packages
o Coordination of Regulatory Meetings with FDA
o Preparation of INDs/IDEs
o Coordination of Drug/Device Master Files (DMF/MAF)
o Preparation of 505(b)(1) and 505(b)(2) NDAs
o Preparation of ANDAs
o Preparation of PMA/HDE and 510K applications
o Preparation of BLAs
o Review of Non-Clinical and Clinical Literature
o Design of Non-Clinical and Clinical Protocols
o Amendments, Supplements, Quarterly and Annual Reports

PDG's full range of pharmaceutical consulting services include but are not limited to:

o Preparation for GCP/GLP and cGMP inspections and follow-up activities
o Assistance with field corrections and recall activities
o Scientific and technical writing
o Preparation of NIH and other grants including CRADA, SBIR, STTR, PEPFAR
o Patent and Trademark assistance
o Quality assurance assistance
o Risk Evaluation and Mitigation Strategies (REMS)
o FDA consultant
o Compilation of SOPs across all functional areas
o Global pharmacovigilance and post marketing surveillance responsibilities
o Regulatory point of contact for both U.S. and international manufacturers

PDG and/or staff of pharmaceutical consultants are members of the following organizations:

o American Association of Pharmaceutical Scientists
o American Pharmacists Association
o BioFlorida
o Drug Information Association
o International Society of Pharmacoepidemiology
o Regulatory Affairs Professional Society
o The Academy of Pharmaceutical Sciences

All of PDG's regulatory submissions have been successful, with no significant deficiencies. Based on these results, many of our clients have asked us to compile multiple additional submissions.

Services: 

Clinical Pharmacology, Clinical Trial Design, Comprehensive Drug and Biologic Development, Consulting, GMP Compliance, Medical Devices/Combination Products, Pharmacovigilance, Regulatory Affairs/Regulatory Strategy, Rx to OTC Switch

Contact Information: 

Pharmaceutical Development Group Inc
13902 N. Dale Mabry Hwy., Suite 230
Tampa, FL, 33618, USA
Phone : 8139633062
Fax : 8139630972
Internet : www.pharmdevgroup.com
Email : cjaap@pharmdevgroup.com
Contact Person : Charles Jaap