Regulatory
The key to a successful submission in the shortest possible time is advanced strategic planning. Qualtran offers strategic regulatory, scientific, and safety planning as early as the preclinical phase, and includes the following :
- Strategic regulatory advice
- Scientific and safety consulting
- Drug development plans
- Expertise in most major therapeutic areas
- Experience with drugs, biologics, botanicals, and medical devices
Preclinical/Toxicology Support
Qualtran regulatory review and support includes preclinical services, such as :
- Consultation and planning
- Preparation/review of reports
- Bridging studies
- Report summarizations for regulatory submissions
Regulatory Agency Interaction
Understanding, communicating, and working with the ICMR(Indian Council of Medical Research) and DGHS (Director General of Health Services) can significantly reduce time for any clinical or development program. Qualtran has extensive experience interacting with the various divisions of ICMR/DGHS. Qualtran’ interactions with the ICMR/DGHS include the following :
- Direct interactions with ICMR/DGHS
- ICMR/DGHS meeting planning, preparation, and presentation
- Advisory meeting support
- Dispute resolution
- Pre-meeting briefing packages
- Post-meeting issue analysis and responses
Pharmacovigilance
Monitoring the safety of patients during any clinical trial is absolutely vital. We provide excellent coordination of clinical and post-marketing safety data collection, processing, and reporting. Qualtran uses one set of Core Operating Procedures and work instructions to ensure customers of consistency, accuracy, and timeliness.
Qualtran’ safety services include :
- Protocol and Investigator Brochure review
- Data collection, evaluation, classification, and reporting
- Medical case reviews
- Safety database development
- Data entry into safety database
- Adverse event narratives and coding
- Regulatory report preparation
Medical Writing
Qualtran has medical writing expertise and experience in most major therapeutics areas. We can help organize and prepare all reports and documentation needed throughout the drug development process – all are prepared in strict accordance with US/EU/ICH guidelines and regulations. A few examples include :
- Dossier writing for marketing applications
- Integrated Summaries of Safety and Efficacy
- Product development plans
- Investigator's brochures
- Protocol and amendment writing
- Clinical study reports
- Patient narratives
Regulatory Support for Clinical Trials
Qualtran’ regulatory affairs professionals provide the following services in support of global clinical trials :
- Approval of investigator packets required for release of investigational product
- Develop/review informed consent forms
- Regulatory requirements for India/US/Europe
- CRF design and preparation