Our Services

We partner closely with our clients, providing experience with large and small pharma/biotech as well as a strong understanding of the drug development process. We engage with you and your team in developing a reasonable project plan with clear milestones, ensuring that your project is on time without sacrificing quality. 

​

Our services include:

​

• Medical Writing for Oncology and Non-oncology indications

• NDA / MAA submissions

• CTD Module writing and support (2.7.3, 2.7.4, 2.5, etc)

• Clinical Study Reports

• Complete protocol support from development to amendments

• Investigator Brochures and updates

• Regulatory response documents

• Safety Narrative writing and review - we have former physicians who can perform complete medical reviews

• Tabular summary and high level analysis in conjunction with subject matter expertise

• Full formatting and document support

• Up to 100% Quality Control (QC) check of data

• Document process control and automation 

​

For more information on how we can help, please contact us at john@socal-med.com or click on the "get in touch" button below. 

​

We look forward to partnering with you!