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Therapeutic expertise

Our consultants have experience in every therapeutic division of the FDA, in many cases, have worked on multiple indications in each area. Whether for a new chemical entity or a generic program, our team understands the development and regulatory hurdles you will face in dealing with the FDA and the various divisions. Our team also has extensive experience working with the European and Canadian regulatory agencies for multiple therapeutic areas and indications.

 

Analgesia

  • Breakthrough pain
  • Chronic pain
  • Acute pain
  • Migraine
  • Tension headache
  • Dysmenorrhea
  • Dental
  • Low back pain
  • Osteoarthritis
  • Post-operational pain
  • Cancer pain
  • Neuropathic pain

Anesthesia

  • Sedation/general

Anti-Infective

  • Community acquired pneumonia
  • Acute exacerbation-chronic bronchitis
  • Tonsillitis/pharyngitis
  • Acute sinusitis (bacterial)

Cardiology

  • Hypertension
  • Unstable angina
  • Arrhythmia
  • Antioxidant
  • Calcium channel blockers
  • Congestive Heart Failure

Central Nervous System – Neurological

  • Parkinson’s Disease
  • Anti-Emetic
  • Migraine
  • Epilepsy
  • Multiple sclerosis
  • Ischemic stroke
  • Head trauma
  • Anti-epileptic
  • Essential tremors

Central Nervous System – Psychiatric

  • Schizophrenia
  • Alzheimer’s disease
  • Insomnia
  • Dementia
  • Depression
  • Psychosis
  • General anxiety disorder
  • Attention deficit hyperactivity disorder
  • Autism
  • Bipolar disease

Dermatology

  • Psoriasis
  • Wound healing
  • Atopic dermatitis
  • Rosacea
  • Acne (cystic)

Devices

  • Cardiac graft
  • Drug delivery system
  • Spinal repair system
  • Diagnostic radiotracer

Diagnostic Devices

  • Strep antigen testing
  • M. tuberculosis nucleic acid amplification
  • C. trachomatis nucleic acid amplification

Endocrinology

  • Menopausal hot flashes
  • Diabetes
  • Reproductive
  • Osteoporosis
  • Obesity/Weight Loss
  • Hypercholesterolemia
  • Hyperthryroidism (primary)
  • Fibrocystic breast disease

Gastroenterology

  • Traveler’s Diarrhea
  • Antiemetics for chemotherapy
  • Antiemetics for post-operative nausea
  • Proton pump inhibitor

Hematology

  • Anticoagulant
  • Sickle cell disease
  • Blood substitutes
  • Ferropenic anemia
  • Anemia secondary to renal failure
  • Anemia secondary to chemotherapy

Infectious Disease

  • Vaccine/Immunizations
  • Avian Influenza
  • Influenza
  • HIV
  • Hepatitis C
  • Hepatitis B
  • Myccobacterium avium complex (MAC)
  • Acute osteomyelitis
  • Chronic osteomyelitis

Nutraceutics

  • Women’s health
  • Metabolic health
  • Gastrointestinal health
  • General wellness
  • Heart health
  • Weight Loss/Obesity

Oncology

  • Non-Hodgkin’s Lymphomas
  • NSCLC
  • CTCL
  • Leukemia (AML, CML, ALL, CLL)
  • Prostate cancer
  • Myelodysplastic syndromes
  • Breast cancer
  • Pancreatic cancer
  • Malignant melanoma
  • Mesothelioma
  • Cancer cachexia
  • Osteocarcinoma
  • Other solid tumors
  • Ovarian Cancer
  • Multiple Myeloma

Ophthalmology

  • Allergic conjunctivitis

OTC/Addicition

  • Smoking cessation (gum)
  • Smoking cessation (patch)

Pulmonary

  • Seasonal allergies
  • Non-sedating antihistamine
  • Allergic rhinitis
  • Asthma
  • Cystic fibrosis
  • ARDS
  • Acute sinusitis
  • Allergy-induced anaphylactic reactions
  • Chronic cough

Rheumatology

  • Rheumatoid arthritis
  • Fibromyalgia

Special Pathogens

  • Tuberculosis
  • Oropharyngeal candidiasis
  • Oral candidiasis
  • Pneumocystis carini
  • Cryptosporidiosis

Transplantation

  • Organ (liver)
  • Organ: kidney

Urology

  • Urinary incontinence
  • Overactive bladder

Vaccines

  • HIV therapeutic vaccine
  • Avian influenza vaccine