Clinipace is pleased to introduce our solution to Covid-19’s interruption of our beloved Taco Tuesdays. Now presenting Regulatory Consulting Tuesday. With Clara Li, Vice President of Regulatory Affairs and Strategic Development. Please join Clara for a 30-minute call to discuss your product, regulatory strategy, and potential product challenges.
Complimentary virtual consulting is available on Tuesday August 4th.
To register, please click here: ‘Schedule a Time’
For further questions or information, please feel free to contact:
- Kevin Boos at email@example.com or 619-339-7325 (San Diego)
- Monica Schmiede at firstname.lastname@example.org or 908-477-0275 (San Francisco)
We look forward to meeting with you.
About Clara Li—Over twenty-eight (28) years in regulatory affairs and strategy with expertise in US, European, and Canadian biotechnology and drug development (Phases I-IV). Lead strategic regulatory roles in the development of therapeutics for a wide range of disease areas for well-characterized biologics, gene therapy, cell and tissue therapy, small molecule, microbiome, vaccines, and combination products. Therapeutic area expertise including oncology, inflammation, cardiovascular, renal, endocrine, neurology, ophthalmology, infectious diseases, and dermatology. Lead teams for submissions and approvals of Orphan, Fast Track, Breakthrough, QIDP, and PRIME. Expertise in assessment of project development paths and technical needs for first-in-human through marketing.
Planned and successfully executed FDA and EU health authority negotiations, submissions, approvals of clinical trial (IND, CTA) and marketing (NDA, 505(b)(2) NDA, BLA, MAA) submissions, review, and life cycle management of dossiers. Expertise in assessing and defining technical and data requirements for expedited development paths and novel development programs. Lead regulatory affairs and strategy group across the US, Europe, and Asia Pacific.