REGULATORY AFFAIRS

Develop a Regulatory Strategy and Plan  

Produce, QC and File documents for Pre-IND/Pre-Submission

Conduct Pre-IND or Pre-Sub Meeting, Produce Minutes

Review, QC, and File Regulatory Submission

Lead FDA or equivalent Regulatory Body Interactions and Activities

​

Provide On-going Regulatory Support 

• Attend team meetings 

• Advice on regulatory topics

• Attend meetings with Pharma partners

• Produce regulatory materials for investor or business development presentations

LANDRICH GROUP

Clinical, Quality, and Regulatory consulting services to Medical Devices, IVD, and Pharmaceutical clients.

CONTACT