Clinical trials | Protocal Design | European clinical trial

	Regulatory Affairs Expertise
	Drugs (new chemical entities and established medicines), Gene Therapy, Devices, Diagnostics, Biologics
	Strategic communications with all major Health Authorities
	Development of regulatory and drug development strategy
	Global regulatory affairs expert
	Collation and organization of health authority correspondence
	Function as consultant VP Regulatory Affairs
	Appeals - clinical hold situations and in cases of failed marketing authorization applications
	Organization of dispute resolution process
	Perform critical reviews of prepared submissions
	European clinical trial applications
	CTAs, INDs, CTXs, NDAs, CTDs, MAAs
	Special protocol, conditional and special circumstance strategies
	Annual Report preparation (INDs, approved products)
	Summary Basis of Approval review and analysis
	INDs and clinical trial applications can be prepared in a Program Management approach where Speid & Associates will develop the global regulatory strategy and then implement the strategy, including starting up and over seeing the company's clinical trial.
	Clinical Research and Operations
	Medical writing
	Protocol design
	Clinical trial design
	Clinical trial monitoring (through collaborator monitors throughout the country) and abroad

	Quality Assurance
	Development of quality strategy
	Development of quality systems
	Training of senior management in quality concepts
	Audits of suppliers, manufacturers, toxicology houses, etc
	Preparation for pre-approval inspections
	Performance of mock-FDA inspections

	Drug Safety
	Development of corporate strategy on safety
	Preparation of safety reports
	Liaison with investigative sites and CROs for development of SOPs for drug safety
	Training in drug safety concepts

	Chemistry Manufacturing Controls
	Manufacturing strategy for drug substance and drug product

Due Diligence Services for Venture Capitalists

Some life science investments pay off, while others do not. A good regulatory and drug development due diligence assessment before you sign that check can reduce the risk of a failed investment. To participate in a verbal (anonymized) survey which is evaluating the reasons some investments are successful and others are not, contact lspeid@sndtm.com

Clinical trial applications and marketing authorizations for China
Development of strategy to include China, conduct of the complete trial in China, or enrollment of patients as part of a multinational trial.

CALL DR. SPEID NOW! Contact Dr. Speid at 858 793 1295 or at lspeid@sndtm.com

"));