Shahid Siddiqui, Ph.D.
Expert in Drug Discovery, Medical Devices (IVDR), and Regulatory Affairs with 15+ years experience
Expert in Drug Discovery, Medical Devices (IVDR), and Regulatory Affairs with more than 15 years' experience in Neurobiology, AI, Bioinformatics, Machine Learning & Precision Medicine, Neurodegenerative and Infectious Disease, Immune-Oncology, Molecular Biology, Biochemistry, Cell Biology and Genetics, Analytical Techniques. CE marks, EUMDR.
Highly collaborative scientist and have developed protocols with and cognizant of ethical and GLP regulatory guidelines as per ICH and FDA, and EMA rules. Key achievements include US Patents for siRNA-based therapies, successful clinical trials (Phase I-III), and significant commercial successes including >$600M sale to Merck Inc. for siRNA technology in eye scar healing and cancer treatment.
HQ:
United States
Languages:
English, Arabic, German, Hindi, Urdu
Claim status:
Claimed
Services & Capabilities
FDA 510(k) Submission Services
Jurisdictions:
US
Services Offered:
Regulatory Pathway Assessment, Device Classification Support, 510(k) Strategy & Authoring, 510(k) RTA Remediation / Refuse-to-Accept Fix, Predicate Research & Substantial Equivalence Strategy, De Novo Strategy & Authoring, PMA Strategy & Support, Pre-Sub / Q-Sub Preparation, FDA Meeting Support (Q-Sub / Type C)
Pathways Supported:
Traditional 510(k), Special 510(k), De Novo, PMA, Pre-Sub / Q-Sub
Device Types Supported:
IVD, SaMD, Medical device
Supports Rta Remediation:
Yes
Supports Predicate Research:
Yes
Years Experience:
22
Ex FDA:
No
Ex Notified Body:
No
Ex Big Medtech:
No
Device Panels:
cardiovascular, neurology, radiology, orthopedic, general_surgery, ivd, wearable_digital
Technology Types:
samd, ai_ml, ivd_test, combo_product
Accepting New Clients:
Yes
