DDReg Pharma

DELIVER BETTER DATA TO ENSURE FASTER APPROVAL

Case Studies

Development of all-inclusive “Global” DMF

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 …

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Biosimilar Market Authorization in Malaysia

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 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 …

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