Global FDA Regulatory Consulting Services

Our global FDA regulatory strategy and product development consulting service partners with our clients to help them mitigate risk. When it comes to developing regulatory strategies, we are experts in examining the nuance which enhances the potential of making the product successful.

Our team has substantial experience with all facets of the international regulatory approval and clearance processes including:

Our strategic consultations employ key knowledge in the area of Regulatory, Clinical, Product Design, Quality Compliance, Commercialization, and overall development feasibility.

Our experience with the FDA and EMA/Notified Bodies as well as key regulatory agencies around the world (e.g., Health Canada, TGA-Australia, DCGI-India, PMDA-Japan, NMPA-China) provide a starting point for developing a regulatory pathway that will evolve into a full development strategy. Partnering with our clients across the development pathway is our goal while providing the nimbleness to utilize our expertise as required in a flexible and scalable model. Examples of our work includes:

FDA Regulatory:

We have very deep experience with obtaining FDA approvals and clearances, obtaining reimbursement codes, and guiding that processes including with dossier submissions, quality compliance, labeling, advertising and promotion, and health economics studies. Our team works hand-in-hand with R&D teams, CMC teams, CROs and CMOs, clinical trials specialists, and our clients' executive teams to expertly drive a drug, medical device, or diagnostic to market.
On behalf of our client, Imeka, we helped obtain a 510(K) clearance for "Automated Radiological Image Processing Software" in conjunction with our collaborators, EVERSANA. The software was cleared to provide automated radiological image processing and analysis tools.
On behalf of our client, CureMetrix, we helped the company obtain 510(k) clearance for "Radiological Computer-Assisted Prioritization Software For Lesions." The radiological computer-assisted prioritization software for lesions is an image processing device intended to aid in prioritization and triage of time sensitive patient detection and diagnosis based on the analysis of medical images. The device offers high sensitivity and specificity >95% AUC.

Members of our IP and FDA Regulatory teams assisted a biopharmaceutical company with the Japenese drug approval of HIYASTA® (tucidinostat 10 mg tablets) in Japan's Pharmeceuticals and Medical Devices Agency (PMDA) through Japan's Orphan Drug designation. The drug is a new active ingredient indicated for the treatment of relapsed or refractory adult T-cell leukemia-lymphoma.
Assisted with the clearance of medical devices under 510(K), 510(K) de novo, and Pre-Market Authorization regulatory pathways.
Identified Orange Book listable innovations and protected the same with patent application submissions.
Helped identify reimbursement stragegies and CPT code procurements.
Identified Risk Evaluation and Mitigation Strategies (REMS) before the US FDA.
Members of our team have assisted with the preparation of Investigational New Drug and New Drug Applications in the US, China and Japan.

We welcome the opportunity to provide you more detailed information about our firm and see how we can work together. Please follow us on Facebook, Twitter, and LinkedIn.

Torrey Pines Law Group, PC serves technology innovators with protecting intellectual property, obtaining regulatory approvals and clearances, and making deals and closing technology transactions throughout the U.S., including in major technology hubs such as San Diego, San Francisco, Palo Alto, San Jose, Silicon Valley, Boston, Cambridge, Chicago, Minneapolis, Houston, Dallas, Atlanta, Denver, Seattle, Portland, Boulder, Orlando, the Research Triangle (Raleigh, Durham, and Chapel Hill), the Mid-Atlantic (New Jersey, New York, Philadelphia, Maryland, Virginia, and Washington, DC), Pittsburgh, Cleveland, Ann Arbor, and throughout Southern California in Los Angeles, Orange County, Irvine, Torrey Pines, Sorrento Valley, and La Jolla.

We have experience with international intellectual property, regulatory and transactional matters pending in Beijing, Shanghai, Shenzhen, and Guangzhou China; Tokyo, Japan; Berlin, Munich and Frankfurt Germany; Tel Aviv Israel; Mumbai, Bengaluru, and New Delhi India; London and Edinburgh United Kingdom; Vancouver, Toronto, Calgary and Montreal Canada; Dublin, Ireland; Cape Town, South Africa; Mexico City and Tijuana Mexico; Brussels, Belgium; Copenhagen, Denmark; Paris, France; Madrid and Barcelona Spain; Moscow, Russia; Santiago, Chile; Montevideo, Uruguay; Buenos Aires, Argentina; Sao Paulo and Rio de Janeiro Brazil; Seoul, South Korea; Taipei, Taiwan; Hong Kong; Hanoi, Vietnam; Bangkok, Thailand; Kuala Lumpur, Malaysia; Milan, Italy; Singapore; Sydney, Melbourne, Perth and Adelaide Australia; Auckland, New Zealand; Oslo, Norway; Stockholm, Sweden; Helsinki, Finland; Kiev, Ukraine; Budapest, Hungary; Vienna, Austria; Prague, Czechia; Geneva and Lausanne Switzerland; Bahrain; Doha, Qatar; Abu Dhabi and Dubai UAE; and Jeddah, Saudi Arabia.