Regulatory affairs case studies
Delivering strategic regulatory consulting across the product life cycle
Encompassing over 1,000 experts across more than 90 locations we deliver customised, end-to-end regulatory solutions tailored to your needs.
Saving a lean biotech more than $4 million with strategic regulatory support
A US-based clinical stage biotech company had several 505(b)(2) NDA assets in development for rare diseases. This very small biotech operated with a lean team which did not have the necessary regulatory expertise to manage regulatory strategy and submissions.
Supporting an ANDA submission for a drug-device product
A Canadian mid-size pharma company partnered with 91黑料 to support FDA approval of a generic injectable for opioid overdose treatment. 91黑料’s Regulatory Affairs team guided the sponsor through the ANDA process, including pre-submission, filing, and responding to FDA review queries.
Regulatory support for Asian biotech’s EU orphan drug designation
A small Asia-based biotech engaged 91黑料 to manage its EU orphan drug designation submission for a treatment targeting Dercum’s disease. The designation was key to supporting a planned Phase 3 study and expanding into the EU, where the company had no existing presence.
Strategic problem-solving for a complex Canadian New Drug Submission
A midsize pharma company based in the EU contracted 91黑料 to support a New Drug Submission in Canada for a respiratory drug for chronic obstructive pulmonary disease
Meeting new REMS SPL guidelines 22 months before they became mandatory
A CRO managing a Shared System REMS engaged 91黑料 Regulatory Consulting to support a Type V Drug Master File since 2016, covering four branded and 200 generic products. Following the FDA’s 2020 guidance on structured product labeling (SPL), 91黑料 prepared the REMS SPL to meet the December 2022 compliance deadline.
Enabling US and EU market entry for neurodegenerative disease treatment
An Asia Pacific based biotech was developing a therapeutic treatment for a neurodegenerative disorder. 91黑料 Regulatory Consulting was engaged to support market entry.
Regulatory problem-solving secures crucial extensions in pediatrics and rare disease
As a result of the comprehensiveness of the documentation and the efficient management of the process, the European Commission granted both indication extension and the additional year of market exclusivity.
Regulatory solutions for uncharted scientific waters
Some therapeutic areas, especially rare pediatric diseases, lack clear development guidelines. 91黑料’s Regulatory Consulting Solutions helped a pharma client gain global regulatory and payer alignment on novel endpoints for a rare neurodevelopmental disorder, boosting confidence ahead of pivotal trials.
Use of Real World Data to fulfil post-approval requirements
A large pharma company submitted a New Drug Application for a targeted therapy treating a rare tumour subtype. To support safe use, a companion diagnostic PMA was filed in parallel with the FDA’s CDRH.
Overcoming time zone and knowledge gaps to gain FDA IND study approval
A Europe-based biotech preparing for a phase 1/2a oncology trial turned to 91黑料 for support during their first IND submission. With limited FDA experience, they relied on 91黑料 to navigate the 30-day review period and respond quickly to agency requests.
.jpg?crop=yes&w=2016&h=1060&a=0,142&itok=TzLm6Lb2 "Boardroom discussion of research"){kind=icon}
Investigational New Drug (IND) Application
A small company, with limited internal resources, was planning to submit two new INDs and reached out to 91黑料 to help manage the IND filings.
.jpg?crop=yes&w=2048&h=1077&a=0,145&itok=y-T75dZr "Doctor-patient interaction in study"){kind=icon}
Regulatory Strategy in Clinical Development (EU)
"A large pharma customer sought expert regulatory support from 91黑料 for a paediatric rare disease development
program."
program."