About Regulatory Strategic Solutions

  We are professionals dedicated to helping companies navigate the complex regulatory and oversight processes of the Food and Drug Administration (FDA). We have experience working with US and global companies in the drug and biologics industries to expedite product development and approval.  

We offer a range of services designed to help our clients effectively engage with the FDA and ensure that their products meet all necessary regulatory requirements.

RSS has a successful track record in development and approval of new drugs and biologics, labeling and indications of an existing product. We engage industry experts with decades of experience in drug and biologics development. We collaborate closely with our clients to develop customized regulatory strategies that align with their business goals, budgets and timelines. Our strategic regulatory guidance not only facilitates success with FDA but also supports early and mid-stage funding rounds,  government and special interest investments, and corporate and investor partnerships.   

Our service offerings include but are not limited to:  

- US Agent and Regulatory Representation; 

- eSubmissions management and liaison; 

- Program and product development gap assessments and solution implementation; 

- Preparation of comprehensive Strategic Development Plans through submission of NDA or BLA; 

- Corporate Quality and Compliance Assessments/Audits; 

- Corporate, technical and GXP training.