What services does Anand Agarwal offer?

Anand Agarwal offers Regulatory Pathway Assessment, Classification Assessment, Predicate Analysis, Test Strategy, 510(k) Authoring & Submission, De Novo & PMA Strategy and other regulatory consulting support depending on project needs.

What pathways does Anand Agarwal support?

Anand Agarwal supports 510(k), PMA, IDE, Post-market, De Novo and related FDA lifecycle activities.

What specialties does Anand Agarwal work in?

Anand Agarwal commonly supports General Surgery, Other device areas.

How much regulatory experience does Anand Agarwal have?

Anand Agarwal has 8+ years in regulatory and quality work.

Anand Agarwal — 510(k) & PMA Consultant (General Surgery/Other)

Q: What regions does Anand Agarwal serve?

Regions served include: United States (FDA), European Union (MDR/IVDR), Canada (Health Canada), Asia-Pacific.

Regulatory Affairs Consultant

Anand Agarwal is a highly accomplished Regulatory Affairs professional with 8 years of experience in the Pharmaceutical, Biologics, and Medical Device industries. He has a comprehensive understanding of global regulatory landscapes, including US FDA, EU MDR, Health Canada, and APAC markets. Anand excels in developing and executing regulatory strategies, compiling complex submissions (INDs, NDAs, 5...

Experience: 8+ years

Submissions: 15 510(k), 3 De Novo, 2 PMA

Expertise & Specializations

Regulatory Pathways

510(k)PMAIDEPost-marketDe Novo

Device Specialties

General SurgeryOther

Regions Served

Anand Agarwal provides regulatory consulting services to clients in:

United States (FDA)European Union (MDR/IVDR)Canada (Health Canada)Asia-Pacific

Credentials & Recognition

Education & Credentials

Possesses a strong academic foundation with an MPharm, an MS in Regulatory Affairs, and an MBA. This comprehensive educational background provides a robust understanding of scientific principles, regulatory frameworks, and business strategy, equipping them to effectively navigate complex regulatory challenges within the pharmaceutical, biologics, and medical device industries.

Professional Experience

A seasoned regulatory affairs professional with extensive experience across the pharmaceutical, biologics, and medical device sectors. Proven track record of success with notable companies, including Moderna Therapeutics, Takeda Pharmaceuticals, and Philips Healthcare. Demonstrated expertise in leading cross-functional teams, managing global submissions for INDs, BLAs, NDAs, and MAAs, and ensuring compliance with FDA, EMA, and ICH guidelines. Adept at post-market surveillance, quality assurance, and medical device safety, consistently driving regulatory success and product lifecycle management.

Former Big MedTech RA Leader
Enterprise experience

Executive Summary

Professional Overview

Core Specializations

Regulatory Pathways

510(k)PMAIDEPost-marketDe Novo

Device Specialties

General SurgeryOther

Services Offered

ISO 13485 Consulting
Quality management system development, gap analysis, and ISO 13485 certification support for medical device manufacturers.

FDA Mock Audit
Pre-inspection preparation, mock FDA audits, and readiness assessments to ensure compliance before official FDA inspections.

ISO 14971 Consulting
Risk management system development, risk analysis, and ISO 14971 compliance support for medical device risk management.

Regulatory Pathway Assessment
Strategic assessment to determine the appropriate FDA regulatory pathway (510(k), De Novo, PMA) for your medical device.

510(k) Authoring & Submission
Complete 510(k) submission preparation, documentation authoring, and FDA submission management.

De Novo & PMA Strategy
Strategic planning and support for De Novo and PMA pathways, including clinical trial design and FDA meeting preparation.

QMS Setup & Implementation
Quality management system design, implementation, and validation to meet FDA and ISO requirements.

Post-Market Support
Post-market surveillance, adverse event reporting, and ongoing regulatory compliance support.

Cruxi Independent Snapshot

Best suited for

• MedTech companies seeking expert regulatory guidance

Experience signals

Regions: US, EU, CA, APAC
Background: 8+ years of regulatory experience.

Cruxi view

This seasoned Regulatory Affairs consultant, Anand Agarwal, stands out for their unparalleled depth of regulatory expertise, spanning 8 years of experience across the pharmaceutical, biologics, and medical device industries. With a comprehensive understanding of global regulatory landscapes, including US FDA, EU MDR, Health Canada, and APAC markets, they excel in developing and executing regulatory strategies, compiling complex submissions, and managing post-market surveillance. Their notable achievements include successfully managing global submissions for INDs, BLAs, NDAs, and MAAs, and representing clients in agency meetings to secure approvals. This consultant's extensive experience, including with companies like Moderna Therapeutics, Takeda Pharmaceuticals, and Philips Healthcare, solidifies their position as a trusted expert in regulatory affairs. Their proficiency in regulatory tools and systems, such as Trackwise, Veeva Vault, and GRA-RIMS, further enhances their value proposition. By leveraging their expertise, medtech companies can ensure robust regulatory compliance and successful product lifecycle management.

This analysis is generated by Cruxi AI using public information and may not capture the full scope of the consultant's experience.

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