Aclairo® Pharmaceutical Development Group, Inc. is committed to delivering independent and objective nonclinical and regulatory advice to the pharmaceutical industry. Every member of Aclairo’s staff strives to provide our clients with superior advice, analysis, work product and program assistance.
Unparalleled Industry Experience
Aclairo’s unique experience and capabilities help our clients’ development programs succeed. Our senior consultants are experienced ex-FDA or industry specialists and can provide expert guidance in the areas of toxicology, regulatory, ADME and clinical pharmacology drug development. In addition, our scientific services group can provide full program management and study monitoring and are experienced in supporting the gamut of regulatory document preparations including:
- Final Study Reports
- Regulatory Applications
- Investigator Brochures
- Expert Reports
- FDA Response Documents
Aclairo’s organizational structure allows us to customize our services to suit our clients’ needs.
- Senior Consultants
- Independent Consultants for CMC and Clinical
- Scientific Services
- Scientific Writers (position papers and regulatory submissions)
- Study Monitors (nonclinical)
- Project Managers (toxicology and DMPK)
A Step Above
The broad scope of Aclairo’s experience combined with effective internal procedures put us a step above our competitors. We ensure:
- Focused expertise in regulatory, toxicology and DMPK
- Clients’ needs are matched to the most qualified consultant
- Detailed attention to each client and to every detail
- Client projects are never left stagnant; timelines are established and met
For more details on Aclairo’s services, please visit www.aclairo.com.