One of the fastest expanding technologies on the planet at present is Artificial Intelligence (AI). It has been gaining so much popularity lately that even industry and sector have applications and use cases for it. Even from smart factories using AI to ramp up their production efforts, to the smart assistant in people’s smartphones, AI …
Artificial Intelligence – Impact on The Global Pharma Industry Read More »
IDMP is a progression of five specific guidelines established by the International Organization for Standardization (ISO) that emphasize different identification standards in the pharma industry. These standards establish an internationally recognized framework for uniquely identifying and describing pharmaceutical items, as well as for standardized documentation, coding and product information interchange across global regulators, manufacturers, suppliers …
Identification of Medicinal Products (IDMP) – The Perspective of US FDA & EMA Read More »
Worldwide In-Market compliance A UK based company with manufacturing locations around the globe and a large consumer healthcare portfolio required in-market compliance check for its products all across the globe. The brands were very popular and could not afford to go off the shelf due to non-compliance should an agency inspection happen. DDReg was tasked …
Introduction of Indian Herbal Pain Patch in the USA Manufacturer of a very popular Menstrual Pain Patch with herbal ingredients wanted to introduce the product in USA. The product had herbal constituents sourced from India. With very strict US FDA requirements for importing and selling medicinal products in USA, the company wanted to have the …
Introduction of Indian Herbal Pain Patch in the USA Read More »
POM to P & GSL Switch – First Time for Molecule One of the top Indian multinational companies has been selling an antihistamine in the UK as Prescription Only Medicine (POM). DDReg was assigned with the task to assess the feasibility of change in the legal status of the product and thereafter support the regulatory …
Development of all inclusive “Global” DMF Agencies across the emerging markets have been dealing with lot of ambiguities pertaining to Active Substance. These ambiguities emanate when a number of applicants submit diverse active substance information or Drug Master files (DMFs) on the same active by the same Active supplier (DMF Source). This usually happens when …
Biosimilar Market Authorization in Malaysia Unlike most small-molecule drugs, which are chemically synthesized with highly predictable structures and functions, biologics and biosimilars are pharmaceutical compounds synthesized or extracted from a biological source, often with much more complex structures. Thus, unlike generic medicines in which the active ingredients are identical to the reference small-molecule drug, biosimilars …
UK Registration of a Formulation of a Big Global Brand sourced from 3rd party CMO A UK-based global CHC organization wanted to seek MA for a Fixed Dose Combination analgesic formulation. The product was sourced from a 3rd party CMO.Usually, the 3rd party sourcing is required when the in-house pipeline not able to support markets …
UK registration of a formulation of a big global brand, sourced from 3rd party CMO Read More »
The US Food and Drug Administration (FDA) has recently finalized its guidance to generic drug manufacturers on how to seek drug development information through the controlled correspondence (CC) process. This guidance finalizes the draft guidance issued in Nov 2017 and replaces the finalized guidance issued in September 2015. This update on controlled correspondence with FDA …
The US generic drug industry has grown into a major component of health care, with generic drugs accounting for the vast majority of retail drug prescriptions dispensed. On August 18, 2017, the President of the USA signed into law the Food and Drug Administration Reauthorization Act (FDARA) including the reauthorization of the Generic Drug User …
