Biologics

All services are tailored to our clients unique program needs.  Please contact us to discuss services available for your project.

Regulatory Services

  • Interact and negotiate with regulatory agencies
  • Plan and guide strategic meetings:
    • Pre-pre-IND
    • Pre-IND
    • End of Phase 1
    • End of Phase 2
    • CMC
    • Pre-BLA
    • Advisory Committee
  • Use guidance’s and regulatory intelligence to streamline development programs
  • Lead adversarial response (e.g., hearings, warning letter intercession)
  • Design Orphan Drug and Fast Track approaches
  • Target Product Profiles
  • REMS
  • Develop Pediatric follow-on programs
  • Suggest Formulation and Indication Line Extensions
  • Develop advertising, promotion and labeling
  • Perform mock Inspections for both manufacturing and clinical sites
  • Audit CROs
  • Coordinate Advisory Committee presentations
  • Guide postmarketing surveillance programs
  • Biosimilars planning

Medical and Technical Writing

  • Pre-pre-IND, Pre-IND Packages and INDs
  • BLAs
  • Orphan Drug Submissions
  • Fast Track Designation Requests
  • Clinical summaries and final reports
  • CTDs (including eCTDs)
  • Summary documents
  • Special Protocol Assessment submissions
  • Advisory Committee Presentations
  • IMPD to IND Transformation

Manufacturing Related Services

  • Analysis of excipient choices
  • Formulations Assessment
  • Facility assessment and submission preparation
  • Review quality control procedures
  • Aid in QA Investigations
  • Upgrade Quality Systems
  • Execute cost of goods analysis
  • Review vendor contracts
  • Development reports
  • Audits and Inspections (US and global)
  • Drug Master File generation
  • Validation Master Plan development
  • Change control development (pre- and post-approval)

Clinical Development Services

  • Create and Assess Clinical development plans
  • Prepare clinical trials strategy
  • Develop and review protocols
  • Generate and Review CRF design
  • Statistical Analysis Plan generation and execution
  • Data Management
  • Structure Adverse Experience reporting
  • Draft Investigator’s Brochures
  • Write and edit study reports, publications and regulatory submissions

Preclinical Programs

  • Assess Needs
  • Design preclinical trials
  • Review protocols
  • Pharmacology
    • Pharmacokinetics
    • Pharmacodynamics
    • Toxicology
    • Mutagenicity
    • Single Dose
    • Repeat Dose
    • Toxicokinetics
    • Chronic
    • Reproductive
    • Carcinogenicity
  • Audit studies
  • Assess results
  • Create integrated summaries