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Pharmaceutical Development Group (PDG) is a subsidiary of Biotech Research Group Corporation.

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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: January 24, 2014

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Strategy and Pharmaceutical Development

Pharmaceutical Strategy Consulting – Strategy and Development

Strategic Drug DevelopmentBy PDG Regulatory ExpertJanuary 24, 2014

PDG provides pharmaceutical strategy and development consulting expertise and serves as our clients’ regulatory voice at FDA. Whether you require a 505(b)(1) or 505(b)(2) NDA, PDG employs pharmaceutical industry professionals who routinely and successfully present client-proposed regulatory strategies to the Agency.

Pharmaceutical Development Programs: Implementation and Oversight

Strategic Drug DevelopmentBy PDG Regulatory ExpertJanuary 24, 2014

Pharmaceutical Development Programs – The importance of pharmaceutical industry experience at this critical juncture in the drug development program cannot be understated.

Pre-NDA Meeting NDA Submissions

Pre NDA Meeting and NDA Submission: 505(b)(1)/505(b)(2)

Strategic Drug DevelopmentBy PDG Regulatory ExpertJanuary 24, 2014

PDG has participated in multiple NDAs (505(b)(1) and 505(b)(2)) and sNDAs, including first-in-class drug products, new chemical entities, Rx-to-OTC switches, and fixed-dose combinations.

505(b)(2) NDAs

Combination Products and Combination Drug Therapies

Research & DevelopmentBy PDG Regulatory ExpertJanuary 24, 2014

PDG has extensive experience in the development of drug/device combination products and combination drug therapies, including all IND and NDA requirements for both fixed-dose combinations or co-packaged drugs.

ANDA Submissions

Generic Drug Development: 505(j) ANDAs and Potential Diversification

Strategic Drug DevelopmentBy PDG Regulatory ExpertJanuary 24, 2014

PDG and staff have participated in over one hundred 505(j) Abbreviated New Drug Applications (ANDA) submissions.

Nonprescription OTC Drug Development - Pharma Consulting

Nonprescription OTC Drug Development

Strategic Drug DevelopmentBy PDG Regulatory ExpertJanuary 24, 2014

As regulatory strategists, our view of non prescription drug Product development (aka Over-the-Counter or OTC) certainly includes new OTC launches and Rx-to-OTC switches. However, there are many lesser known nonprescription OTC drug development opportunities that PDG can help with. Click through these four Q&As to learn more.   As you do so, keep in mind…

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