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PDG is your Pharmaceutical Consultant, Biologics Consultant, Medical Device Consultant, and more. PDG is your Regulatory Consultant.


Pharmaceutical Development Group, Inc.
13902 N. Dale Mabry Highway, Suite 230
Tampa, FL 33618

 

Phone: (813) 963-3062
Fax: (813) 963-0972
e-mail: info@pharmdevgroup.com

Drug Applications

PDG is your Pharmaceutical Consultant

Introducing new drug products to the U.S. market in the current regulatory environment is a complex undertaking that can be both lengthy and and expensive. However, developing a relationship with the right FDA consultant, such as PDG, can help limit the resources necessary to achieve FDA approval of your NDA. Whether you require a 505(b)(1) or 505(b)(2) NDA, or an ANDA (505(j)), PDG has developed proven methods of streamlining the pre-approval process to help you launch your product successfully - on schedule and on budget.

Our staff of professionals will work with you continuously to maximize the safety, efficacy and commercial value of your drug product.  PDG's business is all about growing your business, including line extension, strategic planning, additional indications, and more.

Investigational New Drugs (IND) 

  • Pre-IND Briefing Packages and Preparation for FDA Meetings
  • Pre-IND Meetings with FDA
  • Preparation and Submission of INDs
  • Preparation and Submission of Amendments
  • Post-submission IND Reports and IND Maintenance
  • Development of Special Protocol Assessments (SPA)
  • Drug Master Files (DMF)
  • Interactions with FDA
  • Regulatory Consulting

New Drug Applications (NDA); 505(b)(1), 505(b)(2) Applications & Abbreviated New Drug Applications (ANDAs)

  • Preparation and Submission of Complete NDA Submissions employing Original and Common Technical Document (CTD) Formats
  • 505(b)(2) NDA Development Programs and FDA Submissions
  • Preparation and Submission of ANDAs (505(j) Applications)
  • Fast Track Drug Development/Continuous Marketing Applications
  • Orphan Drug Designations
  • Preparation and Submission of Amendments
  • Preparation of Initial and Subsequent Product Labeling (Professional and Patient) 
  • Post-submission NDA Reports and Maintenance
  • Post-marketing Safety Surveillance
  • Quarterly and Annual Reports
  • Point of Contact for Domestic and International Regulatory Agencies
  • Interactions with FDA
  • Ongoing Reviews of Labeling Adequacy
  • Regulatory Consulting