We believe brand interaction is key in communication. Real innovations and a positive customer experience are the heart of successful communication. No fake products and services. The customer is king, their lives and needs are the inspiration.
We at Pragdom Enterprises understand the regulatory compliance and its impact on the quality and safety of the medicinal product and meets the expectation by:
Development of system for Regulatory compliance like SOP and Guidance documents.
Ensure to keep updating registered information as per current ICH and regulatory requirement.
Expertise in evaluation of change control proposed from the API supplier for DMF/CEP updation, Manufacturing site change, Analytical or R&D proposed changes including Complex Site transfer or Formulation changes.
End to End Regulatory Services covering development of Regulatory Strategy.
Support for Scientific advice for complex or innovative dosage form.
Managing various dosage forms – Oral Solid (IR & MR), Oral Liquids, Injectable including OTC product.
Expertise in Generic or hybrid MAA, Branded Generics application, FDC submission, and bibliographic application.
Advice for the selection of Reference product to be used in development and Bio-equivalence study.
We work in conjunction with contract manufacturing site to support during tech-transfer activities in line with registered information and to meet current Regulatory expectation.
