I manage the marketing of DCT Regulatory Affairs Consultants and Training, provide training and consultancy services in Regulatory affairs and clinical research in the following areas:
•Manage as needed various aspects of compilation of content of regulatory filings for eCTD publishing.
•Work with clients to create a regulatory approach for Clinical trials and IND/CTA submissions.
•Assist clients put together documents to submit changes to approved marketed products and annual reports.
•Suggest approach to deal with different levels of detail in  CMC section relevant to the phase of investigation.
Advise clients on compliance concerns regarding preclinical research and clinical trials.
•Coordinate submission activities of drug products and assist in preparation and submission of filings.
•Assist to identify updates in regulatory requirements and address changes relevant to clients’ products.
•Develop strategies and business for the firm by building relationships with customers and the industry/market leaders.
• Employ sales and marketing tools to create DCT Regulatory Affairs Consultants awareness in the market.
• Proactively assess customer feedback to Introduce improvements in business strategies.
•manage the development of online courses such as GMP, GCP, eCTD, CMC
•Review recalls of drugs and natural health products in Canada

 

Dr Job Kiaira