Our Services Include Preparation and Review of:

  • New Drug Applications (NDA)
  • Drug Master Files (DMF)
  • Abbreviated New Drug Applications (ANDA)
  • Annual Reports
  • Amendments and Supplements
  • 501(k) Notifications
  • Investigational Device Exemptions (IDE)
  • Investigational New Drugs (IND)
  • Deficiency Letter and Warning Letter Responses
  • Regulatory Documentation for Submissions

How Can Milano Regulatory Solutions Help Your Firm?

  • By offering solutions designed to optimize your product development program
  • By working “one-on-one” with your technical team
  • By being responsive to your needs, providing consulting services reflecting your goals, and by meeting your timelines

Training Seminars and Professional Development Courses:

  • Analytical Development and Method Validation
  • SOP Writing
  • Change Control Management
  • Failure and OOS Investigations
  • GMP and GLP Training
  • NDA, ANDA, IND, and DMF Application Preparation
  • Quality Systems Inspections
  • Contract Organization Management and Oversight

CMC Regulatory and Product Development Experience in the Following Areas:

Solid Dosage Forms:

  • Amitriptyline Tablets
  • Atenolol Tablets
  • Acyclovir Tablets
  • Tocainide Tablets
  • Amiodarone Tablets
  • Captopril Tablets
  • Cholestyramine Powder
  • Diclofenac Sodium Tablets
  • Diltiazem Tablets
  • Enalapril Maleate Tablets
  • Methazolamide Tablets
  • Metoprolol Tablets
  • Nabumetone Tablets
  • Nadolol Tablets
  • Pemoline Tablets
  • Procainamide ER Tablets
  • Ursodiol Capsules
  • Quinidine Sulfate Tablets
  • Piroxicam Capsules
  • Naproxen Tablets
Liquids

  • Amantadine Syrup
  • Cimetidine Oral Solution
  • Clemastine Syrup
  • Ethosuxamide Syrup
  • Fluphenazine Elixir
  • Prednisolone Syrup
  • Tretinoin Solution
  • Valproic Acid Syrup
  • Lactulose Solution
  • Albuterol Inhalation
  • Metaproterenol Inhalation Solution

Aerosols

  • Epinephrine Aerosol
  • Terbutaline Aerosol
  • Isoproterenol Aerosol
Creams, Ointments, Gels

  • Clobetasol Cream
  • Clobetasol Ointment
  • Desonide Cream
  • Hydrocortisone Enema
  • Hydrocortisone Val. Cream
  • Lidocaine Jelly

Injections

  • Bupivacaine Injection
  • Lidocaine Injection
  • Epinephrine Injection
  • Dopamine Injection
  • Citanest Injection
  • Pancuronium Injection
  • Atropine Injection
  • Bretylium Tosylate Injection
  • Mepivacaine Injection