Regulatory Strategy for Biologics, Small Molecule, Medical Devices, and Combination Products

The value of a comprehensive regulatory strategy is ensuring your product gets to market as fast as possible. We develop efficient and compliant regulatory strategy to drive products to the marketplace. Considering your strategic business and program goals, we build and customize a strategy to achieve successful product development, commercialization, launch, and lifecycle maintenance with lower program risk and cost.

Our goal is for every product to get approved for an accelerated pathway to market, including Orphan Drug Designation, Fast Track Designation, or Breakthrough Therapy Designation. Accelerated pathway submissions rely on data collected through well-designed GLP studies and clinical trials. The regulatory team has the technical understanding of non-clinical and clinical study designs and execution.

We also provide pre / post pharmaceutical toxicology consulting services to design, implement, and manage non-clinical testing programs. Our work spans from first-in-human trials through achieving proof of concept and phase II to full market registration support. Pharmatech's regulatory team has extensive knowledge in developing CMC sections of regulatory submissions for biologics and small molecules. We translate complex analytical methods, product specifications and characterization, and manufacturing processes into regulatory submissions. In addition, we guide clients through the process of preparing and executing a clinical trial. Assisting in every facet of a clinical program through protocol preparation, CRO selection, IRB approval, investigator training, and post-market vigilance for virtual companies as well as established organizations.

Our services are listed in the infographic below.

ACCELERATED APPROVAL PATHWAYS

  • Orphan Drug Status
  • Combination Product Request for Designation
  • Priority Review
  • Breakthrough Products Designation
  • Accelerated Approval Pathway
  • Fast Track Designation
  • Regenerative Medicine and Advanced Therapies
  • Compassionate Use
  • Humanitarian Device Exemption
  • Veterinary Innovation Program

CHEMISTRY, MANUFACTURING, AND CONTROLS (CMC)

  • CMC sections of regulatory submissions
  • CMC program customization
  • Identify and remediate gaps
  • Review reports to include in your submission
    • Development
    • Batch records
    • Characterization
    • Method validation
    • Stability

NON-CLINICAL DRUG DEVELOPMENT

  • Data gap analysis and positioning
  • Toxicology hazard and safety assessments
  • GLP study monitoring
  • Toxicity and biocompatibility
    • Systemic
    • Reproductive
    • Local tolerance
    • Genotoxicity
    • Carcinogenicity
    • Implantation

DEVELOPING CLINICAL TRIAL DESIGN, EVALUATION, AND EXECUTION

  • Clinical trial protocol
  • Investigator's Brochure (IB)
  • Informed Consent form
  • Patient recruitment and retention
  • Oversight of clinical trials and safety reporting
  • Manage relationships with key parties