Consultancy, strategy, and documentation services supporting the pharmaceutical product development process.
Intertek can help your company formulate development strategies for pharmaceutical and medical products, ranging 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 Chemistry, Manufacturing and Controls (CMC) issues such as formulation changes, etc.
- Timing and requirements for regulatory submissions to support ongoing development activities
- Preparation, review, management and filing of submissions worldwide in Common Technical Document (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 nonclinical programs and Quality (CMC) components, and facilitate clinical programs to support registrations worldwide
- Compliance activities, including development of compliance programs and conduct of facility audits for adherence to GLP and GMP standards
Pharmaceutical Consulting Services
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