About Us – NarudPR

Dream Big I Inspiring Solutions

CEO: Robert Rodriguez

As the founder of Narud PR, LLC, I oversee and manage all aspects of relocation, consulting, and logistics services for companies and professionals transitioning to Puerto Rico. My primary focus lies in supporting the pharmaceutical sector by providing:

Relocation Expertise: Streamlining the relocation process for businesses and individuals, ensuring a smooth transition to Puerto Rico.
Logistical Support: Coordinating the movement of personnel, equipment, and resources in compliance with local regulations.
Consulting Services: Advising pharmaceutical companies on regulatory, infrastructural, and cultural dynamics to facilitate successful operations.
Strategic Planning: Developing customized solutions tailored to the unique needs of each client, fostering growth and sustainability in Puerto Rico.

Through Narud PR, LLC, I aim to bridge the gap between international businesses and Puerto Rico’s thriving pharmaceutical industry, driving innovation and economic development.

Vice President & Real Estate Broker (Lic. C-23445)

Jessica Duran

Relocation Specialist at Narud PR

Jessica Duran is an accomplished VP and Real Estate Broker, specializing in managing seamless real estate transactions and providing tailored relocation services. With a unique focus on the pharmaceutical sector, Jessica supports clients relocating to Puerto Rico, offering expertise in navigating the island’s real estate market and ensuring a smooth transition for individuals and businesses.

Chief Regulatory Officer

Kamali Chance, PhD, MPH, RAC

She spearheads biosimilar regulatory strategy and interactions with regulators for the development of biosimilars in highly regulated markets as well as emerging markets.

Dr. Chance has provided global regulatory strategy for number of biosimilar products in development including biosimilars of Enbrel, Remicade, Herceptin, Rituxin/Mabthera, Humira, Avastin, Epogen, Lucentis, Aranesp, Recombinant Insulins, Neupogen/Neulasta, among others.

In the past 10 years, her specific regulatory experience entails the following:

Spearheaded regulatory strategy to meet FDA and EMA requirements for 18 biosimilar products
Spearheaded clinical development plans for 11 biosimilar products
Attended face to face meetings with FDA for 13 biosimilar products including darbepoetin, adalimumab, infliximab, bevacizumab, trastuzumab, GCSF among others
Sought scientific advice from EMA for 13 biosimilar products including darbepoetin, adalimumab, infliximab, bevacizumab, trastuzumab, GCSF among others
Authored or co-authored 14 articles and a book chapter on biosimilars
Regulatory oversight for briefing packages preparation for 13 different biosimilar products to meet FDA/EMA requirements.
Provided regulatory input on 40+ clinical protocols for Phase I and Phase III studies

Dr. Chance has over 25 years of work experience in the healthcare industry, including the last 19 years in regulatory strategy/affairs at CRO, pharmaceutical and biotechnology industries. Dr. Chance has a Ph.D in Nutrition/Nutritional Biochemistry and Masters of Public Health. She has a Regulatory Affairs Certification from the Regulatory Affairs Professionals Society.

Senior Director, Quality Systems

Barbara Araneo, PhD, RAC

Over 25 years work experience in the biologic industry leading companies from R&D to fully cGMP manufacturing. PHD in Cellular Immunology,

Barbara brings deep expertise in scientific understanding of gene therapy development coupled with her regulatory expertise strength.

She has participated in the development of strategies for cell and gene therapy start-up and has designed both clinical and CMC strategies.

In the past 10 years, her specific Quality Assurance experience entails the following:

Development of clinical and regulatory roadmap for Cell and Gene Therapy companies
Defined CMC and Facility Requirements based on FDA newly released Gene and Cell Therapy Guidance
Lead regulatory and inspectional readiness in support of due diligence for Stem Cell Company
Develop overarching quality assurance procedures to management company Quality systems
Develop phase appropriate quality plan to ensure compliance on every development phase
Develop inspection readiness plan from T-6 months to approval
Perform mock inspections to prepare team for regulatory inspection
Prepare users for regulatory inspection
Develop regulatory inspection standard operating procedures to ensure compliance

Dr Araneo has over 25 years of work experience in the healthcare industry, including the last 5 years in Gene/Cell Therapy, pharmaceutical and biotechnology industries. Dr. Araneo has a Ph.D in Cellular Immunology from University of Rochester and Clinical Trail Management from UC San Diego. She has a Regulatory Affairs Certification from the Regulatory Affairs Professionals Society.

Program Management & Business Strategy

Dr. Dinesh Kundu MBBS, MBA

Professional Summary

A professional Business Strategy & Program Management Consultant with over 15 years of experience in the Biotech, Plasma, and Pharmaceutical industries. Renowned for delivering end-to-end biosimilar projects, from cell line development to commercialization, across the US, EU, and ROW markets.

Core Expertise

Techno-Commercial Leadership: Proven ability to connect stakeholders across R&D, Quality, Manufacturing, Commercial teams, and Top Management to ensure seamless project execution.
Biosimilar Product Knowledge: Comprehensive understanding of regulatory, clinical, and development requirements for key biosimilar products, including cytokines, monoclonal antibodies, and insulin analogues.

Regulatory & Audit Experience

Integral participant in multiple FDA meetings, EMA scientific advice sessions, and audits by international regulatory bodies.
Successfully navigated:
- 2 FDA audits
- 3 EMA audits
- Reviews by INVIMA, ANVISA, and Health Canada

Strategic Accomplishments

Developed and executed business and clinical strategies for leading biosimilar companies in ROW markets.
Played a pivotal role in securing product approvals through regulatory and compliance expertise.

Business Strategy & Program Management Consultant with 15 years of experience in Biotech, Plasma and Pharmaceutical Industries
Extensive experience in delivering Biosimilar projects from cell line to commercialization for US, EU and ROW markets
Techno-commercial expertise and experience to connect all stakeholders in the value chain – R&D, Quality, Manf, Commercial teams and Top Management
Product specific knowledge of Regulatory, Clinical and Development Requirements for the following biosimilar products:
- Cytokines
- Monoclonal antibodies
- Insulin Analogues
Integral part of multiple FDA meetings, EMA Scientific advices and audits by various regulatory bodies
- 2 FDA audits
- 3 EMA audits
- INVIMA
- ANVISA
- Health Canada
Developing Business and Clinical Strategy for top Biosimilar Companies across ROW markets

Why

Choose Us

Puerto Rico Act 60

Act 60, also known as the Puerto Rico Incentives Code, provides significant tax benefits for individuals and businesses relocating to Puerto Rico. This comprehensive incentives package includes:

4% corporate tax rate for eligible businesses
100% tax exemption on dividends
75% exemption on property taxes
50% exemption on municipal taxes
Tax-free interest and dividends
Special tax treatment for capital gains

Our team provides comprehensive support throughout the Act 60 application process, ensuring compliance and maximizing benefits for your business.

Technical Talent Benefits

Puerto Rico offers unique advantages for highly technical resources and hard-to-recruit positions:

Access to a skilled bilingual workforce
Lower operational costs compared to mainland US
Strong intellectual property protection
US legal framework and currency
Strategic location between North and South America
High-quality education system producing STEM graduates

For technical professionals relocating to Puerto Rico, we offer:

Comprehensive relocation assistance
Housing and school search support
Cultural integration programs
Local networking opportunities
Ongoing support for professional development

10+ years of experiences for give you better results.

With over a decade of experience, we specialize in helping businesses and professionals seamlessly transition to Puerto Rico while leveraging the benefits of Act 60 and the island’s unique advantages. Whether you're a company seeking tax incentives or a technical professional looking to relocate, our comprehensive support ensures success every step of the way.