Qu Consulting

Have a regulatory challenge? 
Want help with Quality Remediation? 
Want guidance on filing for an ANDA or MAA? 
Need help with navigating the challenges of filing for drug approval?

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Qu Consulting

Founded to fill a gap in the market, Qu Consulting provides expert technical, regulatory, compliance and governmental affairs services to small and medium sized enterprises around the globe.

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The U.S. Food and Drug Administration approved Zurzuvae (zuranolone), the first oral medication indicated to treat postpartum depression (PPD) in adults.

The U.S. Food and Drug Administration issued a draft guidance which, once finalized, will assist cosmetics companies submitting cosmetic product facility registrations and cosmetic product listings, including ingredients, to the FDA.

The U.S. Food and Drug Administration approved Abrysvo (Respiratory Syncytial Virus Vaccine), the first vaccine approved for use in pregnant individuals to prevent lower respiratory tract disease (LRTD) and severe LRTD caused by respiratory syncytial virus (RSV) in infants from birth through 6 months of age.

The The U.S. Food and Drug Administration has approved Tyruko (natalizumab-sztn), the first biosimilar to Tysabri (natalizumab) injection for the treatment of adults with relapsing forms of multiple sclerosis (MS).

Bimervax, the COVID-19 vaccine developed by HIPRA Human Health, has been authorised by the Medicines and Healthcare products Regulatory Agency (MHRA).

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