PDG continues to lead the pharmaceutical industry as pharmaceutical regulatory and pharmaceutical product development strategists. The design and execution of successful product development and regulatory approval programs are the foundation upon which PDG was built. Our experienced and highly trained staff enjoys a long history of work involving FDA, including CDER, CBER, CDRH and others.  PDG's unique expertise permits us to address all components of the regulatory submissions relating to OTC and prescription drug products (both generic and innovator products), biological products and medical devices.
PDG's experience includes the design, execution and oversight of all phases of product development, including strategic design of regulatory programs, all phases of clinical studies (Phases I-IV), nonclinical programs, formulation and CMC related assignments, manufacturing practices, statistical assignments, post-marketing compliance and pharmacovigilance programs. PDG will also assist in the analysis of the market viability of your product concept. PDG's regulatory submission expertise includes, but is not limited to: | Investigational New Drugs (IND) | | | | Pre-IND Briefing Packages and Meeting Preparations | | | | Pre-IND Meetings with FDA | | | | Preparation and Submission of INDs | | | | Post-submission IND Reports and Maintenance | | | | Interactions with FDA | | New Drug Applications (NDA) | | | | Pre-NDA Briefing Packages and Meeting Preparations | | | | Pre-NDA Meetings with FDA | | | | Preparation and Submission of Complete NDA Submissions employing Original and Common Technical Document (CTD) Formats | | | | Post-submission NDA Reports and Maintenance | | | | Interactions with FDA | | | | 505(b)(2) NDA Development Programs and FDA Submissions | | | | Fast Track Drug Development/Continuous Marketing Applications | | | | Orphan Drug Designations and New Drug Applications | | Abbreviated New Drug Applications (ANDA) | | Drug Master Files (Drug Master Files) | | Biological License Applications (BLA) | | Amendments and Supplements for INDs, NDAs, and BLAs | | Investigational Device Exemptions (IDE) | | Premarket Notifications (510)(k) | | Premarket Approvals (PMA) | | | | Traditional PMAs | | | | Modular PMAs | | | | Streamlined PMAs | | | | Amendments and Supplements | | Product Development Protocols (PDP) | | Humanitarian Device Exemptions (HDE) | | Master Files for Devices (MAF) |
Postmarketing Surveillance | Quarterly and Annual Reports | | Pharmacovigilance Activities (pre and post-marketing) |
 For complete details on how PDG can assist with your regulatory submission, please contact us.
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