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Accelerating access to Women’s Health products

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Customer Requirement: Women’s health and fertility are vital aspects of their overall well-being, and yet they often remain shrouded in silence and misconception. Every woman has the right to access healthcare, irrespective of their socioeconomic background or geographical location, though many women face significant challenges and barriers that restricts their access to the medications they […]

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Web-based Lifecycle Management Tool

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Customer Requirement: A Non-profit organization faced challenges in tracking and monitoring the registration status of their products in respective regions. This is because they had one product  in multiple markets that were each in different stages of their lifecycle. Siloed and disconnected tracking systems meant that the organization was left with little insight into the

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Indian Herbal Pain Patch in the USA

Introduction of Indian Herbal Pain Patch in the USA

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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.

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POM to P & GSL Switch

POM to P & GSL Switch – First Time for Molecule

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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

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Development of all-inclusive “Global” DMF

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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

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Biosimilar Market Authorization in Malaysia

Biosimilar Market Authorization in Malaysia

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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

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UK registration of a formulation of a big global brand, sourced from 3rd party CMO

UK registration of a formulation of a big global brand, sourced from 3rd party CMO

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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

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