Scientific and Regulatory Writing

  • Clinical protocols
  • Informed consents
  • Investigator brochures
  • Review of statistical analysis plans
  • Clinical study reports
  • Scientific publications
  • Book chapters
  • Slide presentations
  • Abstracts, posters
  • American Medical Association Manual of Style

Canadian Regulatory Affairs

  • General consulting and regulatory strategy
  • Clinical trial applications (CTA)
  • Electronic common technical document submissions (eCTD)

Clinical Research

  • Phase 1 to 4 clinical trials including investigator-initiated studies
  • Data management
  • Project management
  • Monitoring
  • Pharmacovigilance
  • Quality assurance (SOP)

INDICATIONS/PROCEDURES

  • Acne
  • Aesthetic procedures
  • Alopecia areata
  • Amyotrophic lateral sclerosis
  • Atopic dermatitis
  • Cardiac disorders
  • Crohn’s disease
  • Feminine health
  • Hyperhidrosis
  • Obstructive sleep apnea
  • Oncology
  • Overactive bladder
  • Pharmacokinetics
  • Photodynamic therapy
  • Psoriasis
  • Rosacea
  • Skin aging
  • Ulcerative colitis
  • Vascular inflammation

Products

  • Pharmaceutical drugs
  • Biological drugs
  • Natural health products
  • Cosmetics