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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

Daily Archives: July 24, 2020

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Pharmacovigilance consultants

Pharmacovigilance Consultants – a Consultant Service for Medical Products

Pharmacovigilance consultantsBy Third-Party ContributorJuly 24, 2020

Medical products, even though the solution to many ills, have also been revealed as a possible source of adverse events or side effects. The role of Pharmacovigilance consultants is the recognition of drug or device risks, whether caused by quality defects, by intrinsic toxicity of the product, by idiosyncratic reactions of the individual, or by…

Regulatory Affairs Services

An Overview of Regulatory Affairs Services

Regulatory Affairs ServicesBy Third-Party ContributorJuly 24, 2020

In the era of competition and globalization the demand for Regulatory Affairs Services are increasing rapidly. These services having a deep connection with health care sectors such as those dealing with the new SARS pandemic. Small-scale as well as big-scale companies are contracting these services through consultants on an everyday basis. Many types of companies…

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