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  • 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
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      • Specialty Services
      • Citizen Petitions
      • Legal Support
      • Literature Searches
      • Pharmacokinetic Consulting
      • Quality Assurance & Compliance
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      • Supplier/Vendor Selection and Qualification
      • Toxicology Consulting
  • Regulatory Updates
  • About PDG
    • About PDG – An FDA Regulatory Consultant
    • Your Pharmaceutical Consultant
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  • Regulatory Resources
    • Regulatory Resources
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Daily Archives: August 12, 2019

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Drug Development Services

FDA Communications: Part II

Strategic Drug Development ServicesBy PDG Regulatory ExpertAugust 12, 2019

As a continuation of FDA Communications: Part I, this article will discuss the other two major types of communications with the FDA that were not discussed in Part I. As a reminder, there are four major types of communications with the FDA: Administrative meetings and communications Regulatory communications Product application meetings Public administrative proceedings This…

Regulatory Affairs – A key piece in the Pharmaceutical Industry

Other Blog, UncategorizedBy Third-Party ContributorAugust 12, 2019

The pharmaceutical industry is one of the sectors that grow year after year globally. Although it is an indispensable industry to maintain the health of the population, the right to which every human being has, it is also an industry like any other that has the right to obtain economic benefits, which allow it to continue working…

Important aspects of scientific writing

Other BlogBy Third-Party ContributorAugust 12, 2019

In scientific writing, readers must find enough information to analyze the observations, repeat the experiments and evaluate the processes that led to their research and to achieve this author must keep in mind that the goal is to effectively communicate the result of the research. Keeping in mind the three basic principles of scientific writing…

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