We recognize the importance of timely and accurate Regulatory submissions as well as the need to foster and coordinate a team effort in drug development. Our Regulatory Affairs staff and affiliates have extensive pharmaceutical drug development experience and offer customized regulatory solutions through every phase of product development, review and commercialization.
Regulatory services include:
- Regulatory consultation
- Regulatory document preparation and submission
- Safety Monitoring
Regulatory assistance can be provided for both device and pharmaceutical development, for the FDA or international Regulatory
Agencies.
Essential services include:
- Sponsor representation with FDA or Regulatory around the
world
- Pre-IND submissions and meetings
- Investigational (IND and IDE) applications in the United
States and internationally
- Regulatory filing packages for clinical studies
- Submission and review of Institutional Review Board approvals
for clinical studies
- Regulatory Maintenance: Annual Reports, SAE reports
- Data Safety Monitoring Boards
- Investigator Brochures and regular updates
- Product license applications (NDA, BLA, PMA, Common Technical
Document) in US and Internationally
- Multinational and multilingual regulatory affairs group
- Regulatory expertise covers wide range of therapeutic areas
and types of submissions
- Regulatory consulting services: Global program development,
evaluation and risk assessment
- Innovative approaches to support effective and timely resolution
of regulatory issues
- Proactive liaison and interface with key FDA review and compliance
divisions and international regulatory authorities
- Planning strategies for most effective and timely review
and approval of regulatory submissions
- Investigational products, marketing approvals, drug master
files, orphan drugs and priority review submissions
- Electronic submissions
- Expert reports for EU product submissions
- Post-marketing surveillance/pharmacovigilance
- Development of Standard Operating Procedures
- Development and maintenance of Regulatory Tracking database
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