Pharmaceutical Product Development Consulting Services
Intertek offers consulting, strategy, and documentation services to assist the pharmaceutical and medical industries with the product development process.
Intertek can help your company develop your pharmaceutical and medical product development strategies, from lead candidate selection to final regulatory submissions and post-market activities. Our global perspective and scientific expertise will ensure success by adding efficiency and manageability to your development program.
Pharmaceutical Product Development Services:
- Comprehensive product development strategies meeting international standards, focusing on regulatory and toxicology requirements:
- Nonclinical studies required for next phase of Clinical Development
- Management of CMC issues such has formulation changes, etc.
- Timing and requirements for regulatory submissions to support ongoing development activities
- Preparation, review, management and filing of submissions worldwide in CTD/eCTD format:
- Pre-INDs, INDs, CTAs, BLA, NDAs, NDSs, MAAs, 510(k)s, PMAs, IMPDs, Pre-Submission Briefing documents, Investigator’s Brochures, Annual Reports, Integrated Summaries, etc.
- Scientific writing of nonclinical data (safety), clinical data, and preparation of CMC documents:
- Manage the nonclinical program, Quality (CMC) component, facilitate clinical program to support registrations worldwide
Pharmaceutical Consulting Services
Request more information to see how Intertek can help your organization with Pharmaceutical Product Development Consulting Services.