We help you to scale the heights!

Expert Services

New medicine development can feel like the high jump.  How can you scale the heights required in science, the regulations, guidelines, understanding of patient needs, to name only a few areas?

The number of novel molecules that are taken through to approval each year has hovered at about 35 for years.  Given the hundreds of thousands of molecules worked on each year, the rate of failure is clearly high.  How can you and your team maximize the chances of success? Predictability is crucial.

The team you select predicts for success or failure. Speid & Associates are experts in new medicine development, including global and strategic regulatory affairs, the area that most often causes failure.   

Only some of the expert services available are described on this page.  If you do not see the service you need,  email LSPEID@SNDTM.COM, start a chat, or call Dr. Speid at 001 858 531 6640.

iStock-538206899-1024x683 Services

Global and Strategic Regulatory Affairs

  1. Regulatory strategy services
  2. IND / CTA  Application
  3. Clinical Trial Applications
  4. New Drug Applications
  5. Biological Applications
  6. Orphan drug regulatory affairs services 
  7. Rare disease regulatory affairs

Clinical Research

  1. Clinical Protocol
  2. Informed Consent
  3. Investigator's Brochure
  4. Clinical Study Report
  5. Rare disease clinical research

Chemistry Manufacturing and Controls

  1. Strategy Development
  2. Drug Substance
  3. Drug Product
  4. Sterilization
  5. Stability Studies
  6. Release Profiles
  7. Analytical Development

Drug Safety

  1. Toxicology strategy development
  2. Toxicology protocol development
  3. Predictive value of tox studies
  4. Serious adverse reaction analysis
  5. Liver toxicology
  6. Cardiac toxicology
  7. Clinical hold resolution
  8. Integrated Safety Reports 

Informed Consent

We will work with you to develop the Informed consent process and form. This involves training the investigators and their staff for the clinical studies. 

Company Presentation

Find out about our services. Email LSPEID@SNDTM.COM for a copy of the Company presentation:

1. General Presentation

2. Detailed Presentation of Services

3. Presentation of Biosimilar Services