Services

We offer wide range of services related to bringing your drugs to market faster. Please click on the title of the service for details.

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Pharmaceutical Advisory Dream Team (PADT)

Target Health Inc.'s Pharmaceutical Advisory Dream Team (PADT) consists of a focused, fast-moving and motivated team of highly successful individuals with over 400 years of combined experience in all aspects of pharmaceutical research and development, including: chemistry, product and process development, manufacturing, toxicology, regulatory affairs, clinical research, biostatistics, registration and marketing.

Regulatory Affairs

  • Meet with the FDA to discuss and negotiate development strategies
  • Prepare and submit:
    1. Pre-IND/IDE briefing documents
    2. IND and IND amendments
    3. IDE
    4. 510(k)
    5. NDA
    6. BLA
    7. PMA
    8. DMF
    9. Export requests
    10. Establishment registrations
    11. Orphan Drug requests
  • Interact with legal counsel
  • Assure that user fee monies are submitted on schedule
  • Follow up with FDA on post-NDA submission questions
  • Perform pre-inspection GMP audits
  • Support responses to FDA questions and warning letters
  • Adverse event monitoring and reporting

Clinical Research

  1. Prepare protocols, case report forms and informed consent forms
  2. Perform qualification, initiation, monitoring and closeout visits
  3. Generate investigator study files
  4. Monitor drug supply
  5. Identify study sites and manage investigator payments
  6. Prepare clinical sites for FDA inspection
  7. Perform Quality Assurance audits

Data Management

  • Target e*CRF® Internet-based data collection and project management
  • Data Management Plans
  • Data Listings
  • Edit check specifications
  • Batch edit checks
  • Online clinical data management
  • MedDRA coding
  • WHO Drug Coding

Biostatistics

  • Statistical Analysis Plans
  • Calculate sample size
  • Generate randomization codes
  • Perform statistical analyses using Statistical Analysis System (SAS®)
  • Prepare electronic files, with documentation, in SAS®

Medical Writing

  • Write integrated clinical and statistical study reports and other regulatory manuscripts
  • Orphan drug designation requests
  • NDA Submissions
    1. application summary
    2. chemistry, manufacturing and controls
    3. labels and labeling
    4. non‑clinical pharmacology and toxicology
    5. human bioavailability
    6. clinical/statistical sections including ISS/ISE
    7. benefit/risk
    8. drug abuse and overdose