With a laser-like emphasis on results and value, healthcare is fast moving to a new world of patient choice. Indeed, healthcare systems that have historically emphasized medical treatments based on episodic interactions with patients are now realizing the need to fully comprehend external variables and provide ongoing care. Exogenous factors like genomics, conduct and social […]
Expanded use of RWE (Real World Evidence) Read More »
One of the fastest-expanding technologies on the planet at present is Artificial Intelligence (AI) in the pharma Industry. It has been gaining so much popularity lately that even industries and sectors have applications and use cases for it. Even from smart factories using AI to ramp up their production efforts, to the smart assistant in
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 »
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 to carry out
Worldwide In-Market compliance Read More »
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 right regulatory strategy, as the business opportunity was big.
Introduction of Indian Herbal Pain Patch in the USA Read More »
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 strategy by way of developing safety rationale with regulatory documentation in
POM to P & GSL Switch – First Time for Molecule Read More »
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 each applicant asks the API supplier
Development of all-inclusive “Global” DMF Read More »
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
Biosimilar Market Authorization in Malaysia Read More »
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 or when there is a local/regional business need for a client. For getting a
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
Controlled Correspondence with FDA – An Update Read More »
