We proudly earned our reputation for insight-driven, creatively bold solutions helping companies navigate the 505(b)(2) regulatory pathway, and have since established ourselves as a full-service partner of choice for pharmaceutical product development companies in 25 countries around the globe.
Understanding the strategic importance of regulatory agencies in the product development pathway, we’ve established unmatched experience with the FDA along with proven expertise in the development of enhanced medicines to treat patients with rare, chronic and complex conditions. With frequent interactions across all divisions, we productively engage with regulatory agencies to produce the best outcomes for our clients and for patients.
Pursuing quality and excellence through scientific rigour, continuous improvement, and precise execution, to create extraordinary value, we’ve acquired deep and broad therapeutic experience since our start in 2003:
- Consulted on products spanning 27 therapeutic areas
- Partnered on more than 100 projects each in analgesia, oncology, metabolism, gastroenterology, cardiovascular, women’s health and neurology
- Participated in more than 1,150 meetings across all FDA divisions
- Involved with more than 250 NDA and ANDA approvals
- Achieved a 98% FDA first-pass approval rate
Our scientifically credible, customized development solutions cover a range of therapies, including:
- Enhanced medicines, including 505(b)(2) and related pathways
- Treatments for rare and ultra-rare diseases
- Drug-device combinations
- Complex generics
- FDA-regulated digital health products
- DESI products
Camargo goes well beyond our original focus in regulatory strategy, bringing together critical elements for a successful development program.
- Cross-disciplinary team of experts
- Business and commercial expertise
- Emphasis on effective project management
- Commitment to quality