Regulatory Affairs

Our extensive experience and hands on background helps our clients through all of the regulatory hurdles while avoiding the pitfalls and missed opportunities associated with meeting the vast set of requirements.

• IND/IMPD/DMF/NDA/MAA expertise for drug substance and drug product eCTD authoring. 
• Design and implement regulatory strategies for pharmaceutical and combination products for early stage through commercialization.
• Regulatory agency meeting CMC oversight (Pre-IND, EOP2, Pre-NDA, Type C).
• Change control management for all stages.
• Technical CMC report authoring.
• Advice on developmental, manufacturing, analytical, and supply chain challenges in relation to RA CMC.
• Integrate with nonclinical and clinical development programs to ensure product availability.
• sNDA strategy, authoring, and filing.