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  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
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.


Contact Dr. Speid at 858 793 1295 or at lspeid@sndtm.com

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