Pharmaceutical Development Group (PDG) is a subsidiary of Biotech Research Group Corporation.
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Pharmaceutical Development Group
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- Pre-NDA Meetings and NDA Submissions: 505(b)(1)/505(b)(2)
- 505(b)(2) NDAs
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- Nonprescription Drugs (OTC)
- Medical Device Consulting
- Post-Launch Activities
- Specialty Services
- Regulatory Updates
- About PDG
- Regulatory Resources
- Contact PDG
- 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
- Post-Launch Activities
- Specialty Services
- Regulatory Updates
- About PDG
- Regulatory Resources
- Contact PDG
FDA Pre-submission Direction Guidance
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- FDA Pre-submission Direction Guidance