Therapeutic Expertise Across the Development Space

Integrated Therapeutic Solutions Inc. authors a wide variety of medical, scientific and regulatory documentation that effectively communicates pharmaceutical and medical device information to various stakeholders, including clinical investigators, institutional review boards, medical monitors, study coordinators, and regulatory reviewers. We offer medical writing as an integral part of a full drug development program, a Phase I-IV clinical trial or as a stand-alone service.

We support preparation of all regulatory documents, including:

  • Preclinical And Scientific Reports
  • Investigator Brochures
  • FDA Briefing Documents
  • Phase I-IV Clinical Protocols
  • Phase I-IV Statistical Analysis Plans (SAPs)
  • Investigational New Drug Applications (INDs)
  • Global Clinical Trial Applications (CTAs)
  • Investigational Device Exemption (IDE) Applications and 510(k)s
  • New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs)
  • Biologics License Applications (BLAs)
  • Integrated Summaries of Safety/Efficacy
  • Informed Consent Forms/Patient Information sheets
  • Patient Safety Narratives
  • Premarket Approval (PMA) Applications
  • Case Report Forms (annotated and full-length)

Additionally, we provide both drug and medical device support for post-approval services including:

  • Product monographs
  • Package Inserts
  • Product launch support documents
  • Posters and symposia publications
  • Patient education materials, newsletters and brochures
  • Manuscripts, study reports, slide kits, and dossiers

All medical documents are subjected to rigorous internal reviews, fact-checking and quality control procedures to ensure compliance with style guides and regulatory guidelines.

Our dedicated team of experienced writers includes professionals with diverse scientific training. Collectively our writers have experience in virtually all therapeutic areas. At Integrated Therapeutic Solutions, Inc., we work with our clients to match writers with their projects needs – delivering content from a clinical, pharmacological or regulatory perspective. We use medically intelligent writing that is thoughtful and meaningful, with sensitivity to the drug class and therapeutic area.

  • Allergy
  • Immunology
  • Cardiovascular
  • Central Nervous System (CNS)
  • Dentistry
  • Dermatology
  • Endocrinology
  • Gastrointestinal (GI)
  • Hematology
  • Infectious Diseases
  • Metabolics
  • Neurology
  • Opthalmology
  • Oncology
  • Orthopedics
  • Pediatrics
  • Psychiatry
  • Respiratory
  • Rheumatology
  • Transplantation