Case Studies
Success Stories
Discover how BETS has helped clients navigate complex regulatory landscapes and achieve their development goals.
50+
Projects Completed
25+
Years Experience
100%
Regulatory Success
Global
Market Reach
Pharmaceutical
Global Toxicology Strategy & Regulatory Submission
Challenge
A mid-sized pharmaceutical company needed comprehensive toxicology support for a novel small molecule drug from IND-enabling studies through global regulatory submissions.
Solution
BETS developed a customized toxicology strategy aligned with FDA, EMA, and PMDA requirements. We coordinated CRO selection, monitored GLP studies, and prepared the nonclinical sections for regulatory submission.
Outcome
Successful IND submission with no clinical holds. The program progressed to Phase 2 trials with full regulatory acceptance across all targeted markets.
Generic Pharmaceuticals
Impurity Qualification & Nitrosamine Risk Mitigation
Challenge
A generic drug manufacturer faced regulatory concerns regarding nitrosamine impurities and needed urgent risk assessment and mitigation strategies.
Solution
Our team conducted comprehensive (Q)SAR analysis, performed nitrosamine risk assessment, and established appropriate AI limits. We prepared quality reports for regulatory submission.
Outcome
Regulatory approval maintained with documented risk mitigation. The client avoided product recalls and established robust quality systems for ongoing compliance.
Contract Research Organization
Facility Design & GLP Readiness
Challenge
An emerging CRO in India required complete facility design and qualification support to achieve GLP certification and AAALAC accreditation.
Solution
BETS provided end-to-end support from concept design through operational qualification, including quality system establishment, staff training, and mock audit preparation.
Outcome
Successful OECD GLP certification achieved within 18 months. The facility also received AAALAC accreditation, enabling international client partnerships.
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