cro

The only full-service dermatology CRO that takes products from concept to approval

Product Development Planning

CRO Services |Clinical Operations, Regulatory Affairs & Data Management

Our development team will help you formulate a plan to guide your drug, biologic or medical device through the regulatory pathways to approval:

  • Roadmap of key activities and deliverables
  • Integrate CMC, non-clinical and clinical development to maximize efficiency, reduce costs and increase development velocity
  • Manage project from concept to market
  • Manage manufacturing site selection, qualification and oversee technology transfer

Non-clinical Development

  • Design and manage pharmacology and toxicology programs
  • Develop and manage formulation and analytical chemistry; define and manage formulation development
  • Develop CMC sections for regulatory submissions
  • Review the development of analytical, stability and formulation programs to support regulatory filings
  • Perform risk analysis for CMC issues related to NCEs

Clinical Development

  • Design General Investigational Plans
  • Develop clinical protocols, CRFs and consent forms for Phase 1-4 studies
  • Develop CRF guidelines and investigator brochures
  • Author CSRs, ISSs and ISEs
  • Medical monitoring
  • Data Management oversight
  • Select, contract and manage qualified clinical investigators
  • Investigator meeting services
  • Prepare and submit documentation to central IRBs

Regulatory Affairs

  • Strategic regulatory planning and implementation during all phases of development
  • Monitor changes in regulations related to drug/device development
  • Prepare, review, file and maintain regulatory submissions (e.g., INDs, NDAs, BLAs, CTDs, IDEs, PMAs, 510(k)s, etc.)
  • Help clients prepare for agency audits/inspections
  • Represent clients at FDA meetings

Let us lead your dermatology product development program through the complex maze of non-clinical, clinical and regulatory hurdles to an FDA approval.Get started