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.
About
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.
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.
Additional information
### **Additional information**
- **Type:** independent
- **Years of experience:** 22
- **Regions served:** US, EU, APAC
- **Client types:** startup, sme, large_medtech, academic
- **Location:** United States (Illinois)
- **Availability:** available_now
- **Certifications:** Food & Drug Administration - eDRL -Drug Labeling Guidance Certificate, Generic Drug Small Business Admin.
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### **Cruxi analysis**
- **Strength summary:** Shahid Siddiqui, Ph.D. is a seasoned expert in medtech regulatory affairs, boasting an impressive 22 years of experience and a strong background in drug discovery, medical devices (IVDR), and regulatory affairs. With 15+ years of expertise in Neurobiology, AI, Bioinformatics, Machine Learning & Precision Medicine, he has developed protocols adhering to ICH and FDA guidelines, resulting in successful clinical trials (Phase I-III) and significant commercial successes. His experience in CE marks, EU MDR, and FDA regulations makes him a valuable asset for medtech companies navigating complex regulatory landscapes.
- **Unique value:** What sets Shahid Siddiqui, Ph.D. apart is his unique combination of FDA experience, device expertise, and technical skills in AI, Machine Learning, and Bioinformatics. His ability to develop protocols that balance regulatory requirements with scientific innovation makes him a valuable asset for medtech companies seeking to bring cutting-edge products to market while navigating complex regulatory landscapes.
- **Ideal projects:** This consultant excels in handling projects involving cardiovascular, neurology, radiology, and IVD devices, with a strong focus on 510(k), De Novo, and PMA submissions. They are particularly suitable for medtech companies, especially startups and SMEs, seeking to navigate international regulatory expansions, complex devices, or first submissions. Their expertise in FDA regulatory affairs, combined with their experience in managing predicate analysis, test strategies, and full 510(k) authoring, makes them an ideal fit for projects requiring a comprehensive approach to regulatory affairs.
- **Last analyzed:** Mon Dec 22 2025 12:24:04 GMT-0500 (Eastern Standard Time)
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### **Qualifications & scope**
- **Submission types:** 510k-traditional, 510k-special, de-novo, pma, clinical-trials, international
- **Device classes:** class-i, class-ii, class-iii
- **Specialties:** cardiovascular, neurology, radiology, ivd, clinical-chemistry, hematology, pathology, software-samd
- **Device panels:** cardiovascular, neurology, radiology, orthopedic, general_surgery, ivd, wearable_digital
- **Regulatory pathways:** 510k, de_novo, pma, ide, q_sub, post_market
---
- **Type:** independent
- **Years of experience:** 22
- **Regions served:** US, EU, APAC
- **Client types:** startup, sme, large_medtech, academic
- **Location:** United States (Illinois)
- **Availability:** available_now
- **Certifications:** Food & Drug Administration - eDRL -Drug Labeling Guidance Certificate, Generic Drug Small Business Admin.
---
### **Cruxi analysis**
- **Strength summary:** Shahid Siddiqui, Ph.D. is a seasoned expert in medtech regulatory affairs, boasting an impressive 22 years of experience and a strong background in drug discovery, medical devices (IVDR), and regulatory affairs. With 15+ years of expertise in Neurobiology, AI, Bioinformatics, Machine Learning & Precision Medicine, he has developed protocols adhering to ICH and FDA guidelines, resulting in successful clinical trials (Phase I-III) and significant commercial successes. His experience in CE marks, EU MDR, and FDA regulations makes him a valuable asset for medtech companies navigating complex regulatory landscapes.
- **Unique value:** What sets Shahid Siddiqui, Ph.D. apart is his unique combination of FDA experience, device expertise, and technical skills in AI, Machine Learning, and Bioinformatics. His ability to develop protocols that balance regulatory requirements with scientific innovation makes him a valuable asset for medtech companies seeking to bring cutting-edge products to market while navigating complex regulatory landscapes.
- **Ideal projects:** This consultant excels in handling projects involving cardiovascular, neurology, radiology, and IVD devices, with a strong focus on 510(k), De Novo, and PMA submissions. They are particularly suitable for medtech companies, especially startups and SMEs, seeking to navigate international regulatory expansions, complex devices, or first submissions. Their expertise in FDA regulatory affairs, combined with their experience in managing predicate analysis, test strategies, and full 510(k) authoring, makes them an ideal fit for projects requiring a comprehensive approach to regulatory affairs.
- **Last analyzed:** Mon Dec 22 2025 12:24:04 GMT-0500 (Eastern Standard Time)
---
### **Qualifications & scope**
- **Submission types:** 510k-traditional, 510k-special, de-novo, pma, clinical-trials, international
- **Device classes:** class-i, class-ii, class-iii
- **Specialties:** cardiovascular, neurology, radiology, ivd, clinical-chemistry, hematology, pathology, software-samd
- **Device panels:** cardiovascular, neurology, radiology, orthopedic, general_surgery, ivd, wearable_digital
- **Regulatory pathways:** 510k, de_novo, pma, ide, q_sub, post_market
---
Key Highlights
- Shahid Siddiqui, Ph.D. is a seasoned expert in medtech regulatory affairs, boasting an impressive 22 years of experience and a strong background in drug discovery, medical devices (IVDR), and regulatory affairs. With 15+ years of expertise in Neurobiology, AI, Bioinformatics, Machine Learning & Precision Medicine, he has developed protocols adhering to ICH and FDA guidelines, resulting in successful clinical trials (Phase I-III) and significant commercial successes. His experience in CE marks, E
- What sets Shahid Siddiqui, Ph.D. apart is his unique combination of FDA experience, device expertise, and technical skills in AI, Machine Learning, and Bioinformatics. His ability to develop protocols that balance regulatory requirements with scientific innovation makes him a valuable asset for medtech companies seeking to bring cutting-edge products to market while navigating complex regulatory landscapes.
Certifications & Trust Signals
- 22 years experience
Buyer Snapshot
Best for
- This consultant excels in handling projects involving cardiovascular, neurology, radiology, and IVD devices, with a strong focus on 510(k), De Novo, and PMA submissions. They are particularly suitable for medtech companies, especially startups and SMEs, seeking to navigate international regulatory expansions, complex devices, or first submissions. Their expertise in FDA regulatory affairs, combine
HQ:
United States
Languages:
English, Arabic, German, Hindi, Urdu
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
