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  • Home
  • Services
    • Pharmaceutical Consulting Services
    • Strategic Drug Development
      • Strategic Drug Development Services
      • Pharmaceutical Development Programs: Implementation and Oversight
      • Pre-IND Meetings
      • Investigational New Drug Application (IND)/Special Protocol Assessment (SPA)
      • Clinical Trial Design
      • Pre-NDA Meetings and NDA Submissions: 505(b)(1)/505(b)(2)
      • 505(b)(2) NDAs
      • Generic Drugs: 505(j) ANDAs and Potential Diversification
      • Nonprescription Drugs (OTC)
    • Medical Device Consulting
      • Exempt Devices / 513(g) Submissions
      • Device Pre-submission Meetings and Reviews
      • Facility Inspection Readiness
      • Combination Device and Drug/Biologic Submissions
      • 510(k) Submissions
      • PMA Submissions
    • Post-Launch Activities
      • Drug Post-Launch Activities
      • Post-Marketing Surveillance
      • Drug Labeling
    • Specialty Services
      • Specialty Services
      • Citizen Petitions
      • Legal Support
      • Literature Searches
      • Pharmacokinetic Consulting
      • Quality Assurance & Compliance
      • Scientific and Technical Writing
      • Supplier/Vendor Selection and Qualification
      • Toxicology Consulting
  • Regulatory Updates
  • About PDG
    • About PDG – An FDA Regulatory Consultant
    • Your Pharmaceutical Consultant
    • Careers at PDG
  • Regulatory Resources
    • Regulatory Resources
    • FDA Links
    • International Health Authority’s Websites
  • Contact PDG

Tag Archives: pharmaceutical research

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The Consulting for the Pharmaceutical Scientist Office

Other BlogBy Third-Party ContributorAugust 14, 2019

As a company, the modern Pharmacy Office needs to know in depth both the state of your business and its environment, to improve your level of Strategic and Commercial Management. How can you achieve this? With the accompaniment of a specialized Consultant, to guide you through the complicated path to business success. But what features…

AN EFFECTIVE STRATEGY FOR IND PHARMACEUTICAL PRODUCT DEVELOPMENT

An Effective Strategy for IND Pharmaceutical Product Development

Research & DevelopmentBy PDG Regulatory ExpertMay 18, 2019

The FDA is comprised of multi-disciplinary experts in chemistry, microbiology, pharmacology, toxicology and other various disciplinaries. It is important to keep in mind that these are the experts that will review your pharmaceutical product development report and data. A key to an effective strategy for IND planning is to know the process for submission. The…

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