Prescribing information for drug and biological products contains a summary of the essential scientific information needed for the safe and effective use of the product. Prescribing information generally includes indications for which the product is used, dose, dosage and method of administration, contraindications, warnings and precautions, adverse reactions associated or likely to be associated with the product, possible drug interactions, information about use in specific populations, and other important information that is useful for healthcare providers in understanding and prescribing a product.
Patient labeling (e.g., patient information leaflets, factsheets, instructions for use) is written for the patient, family, or caregiver for a reasonable understating of the product usage. We can assist you in preparing product labels for new drugs or generic drugs. We can assist in reviewing and updating the draft or existing product labels. Our team has worked and has expertise in handling product labels for prescription drugs, biologicals, and OTC products.
