When you engage I 3 CONSULTING for your next US FDA or EU CERTIFICATION, you gain access to our team of highly qualified, experienced Lead Auditors, Consultants, Medical Writers, who are committed to propelling the future of compliance solutions. We pride ourselves on the qualification and industrial experience of our advisory, professional services team and trainers.

We work closely with our clients on every project, walking through a comprehensive methodology that focuses on closing GAPs to satisfy regulatory requirements, and ultimately achieve clearances and Certifications from authorities. With such an intense focus on individual client needs, it’s common for our solutions specialists to establish long-lasting relationships with our clients, who often think of our experts as extended members of their own teams.

Mr. Ronald Willman

Advisory Board Member

Levingston, England


Former UL head of Medical Device Certification operations, New England. His vast experience in EU medical device regulations for more than 28 years helped many class III Design Dossier File successfully pass through notified Body and FDA review smoothly. Ronald guidance and suggestions are always value addition for I 3 Consulting team of Consultants.


Dr. Satish Kumar

Advisory Board Member

Nellore, India


Former Vice President at Unistem Biosciences Pvt. Ltd., where he was instrumental in the start-up of cGMP lab for processing of bone marrow and other sources of Mesenchymal Stem Cells as well as cryobanking services. His vast experience helps to set up worldwide laboratories and GMP Certification.


Mr. Bobby Sebastin

Advisory Board Member

Kochi, India


An experienced Rubber Technologist with more than 24 years of hands on experience in manufacturing latex, medical disposables and related QMS and Product Certification. His services are offered to various medical device companies in India, Malaysia, Indonesia, Srilanka, Thailand, South Africa, Botswana & the USA. His in-depth knowledge in European & US regulatory requirements in latex devices helped many companies to achieve CE and FDA 510k clearance.


Mr. Jomon Antony

Advisory Board Member

Tampa, USA


A software engineer with 18 years of experience in medical standalone software design, verification, troubleshooting and electronic IFU. His experiences in handling regulatory obstacles with FDA and EU is marvellous.


Mr. Joe Raj Kumar

Projects Head – European Operations

Dusseldorf, Germany


 


Mr. Manoj Zacharias

Projects Head – USA Operations

Chicago, USA


Post Graduate in Business Administration with 17 years of experience in Regulatory Department at various pharmaceuticals in India and the USA. Thorough Knowledge in US FDA guidance for Food, OTC Drugs, Cosmetics and Medical Device Registrations, Listing, Submission and notification procedures. He also act as US Agent for clients across Globe.


Mr. Soio George

Projects Head – Asia Pacific Operations

Bangalore, India


A Pharmacy Graduate with 10 years of pharmaceutical manufacturing experience, 12 years of regulatory consulting experience in GMP and Product Certifications. He gained a breadth of experience in technical knowledge which helps to lead the Medical Device and GMP team in India, Germany and USA.


Mrs. Nadini Muller

Business Development (EAR Service)

Bremen, Germany


An efficient administrator and customer coordinator. Her knowledge in medical device European Authorized Representative regulations helps potential clients to understand the process followed by drafting the agreement and organize Free Sale Certificate (FSC). Her service helps in completing EAR service and FSC smoothly.


Mr. Aryan Bazagar

Authorized European Representative

Bremen, Germany


More than 12 years of Medical Device marketing experience. Acting as our European Authorized Representative for the last many years. He always try to fulfill his responsibilities towards as an EAR. His dedication are awesome!!


Mrs. Maya Anthony

Associate Consultant

Tampa, USA


 


Mrs. Somaja Babu

Associate Consultant

Kochi, India


 


Mrs. Sara Moly

Sr. Marketing Associate (EU)


Sara joined I 3 Consulting in August 2016 as Senior Marketing Associate in EU Regulations. Sara has a passion for creating new customers base every time by guiding clients on the right route. She will be leading all marketing efforts for US FDA in Europe. Sara will be leading all marketing efforts, including brand strategy, content development, social media, website management, Email marketing, and public relations.

Graduate from University of Louisville in chemical engineering. Sara is settled in Mumbai with husband and children. Weekends and holidays she spend time with family, parents and friends.


Mrs. Souzan John

Sr. Marketing Associate ( US FDA)


Souzan joined I 3 Consulting in February 2018 as Senior Marketing Associate (US FDA). Souzan has a passion for creating new customers base every time by guiding clients on the right route. She will be leading all marketing efforts for US FDA in Europe.

Souzan is a graduate of Business Management with BA (Hons) from Liverpool University. Weekends and holidays Souzan enjoys spending time with her husband, family and friends, and exploring new places.


Mrs. Sobha Rachel

Administration (Asia Pacific)

Bangalore, India


Post graduate in Sociology with 9 years of administrative experience. She actively involves in day to day activities related to finance, manpower and overall client relationships. She is pleasing and works diligently to see that each project is well managed and if any concerns will be resolved amicably. She also tries to keep the team spirit of members spread in all 3 offices.


Mrs. Beena P

Principle Consultant (US FDA)


Joined I 3 Consulting in May 2011, prior to joining I 3 Consulting, Beena spent more than 12 years in Medical Device and pharmaceutical manufacturing industry, specializing in Quality Assurance and Regulatory. Being a principle consultant Beena takes the ownership and management’s efforts in the day-to-day implementation of policies, procedures and project timelines. She works diligently to see that each project is well managed and reviewed and communicated to customers while striving to place maximum emphasis on positive responses from clients without any regulatory obstacles during export of goods to USA.

Beena is a Post Graduate in Microbiology from M.G University, presently settled and lives in Bangalore. Outside the firm, she enjoys spending time travelling and exploring places with her industrialist husband, kids and friends.


Mrs. Dheepa

Sr. Consultant & Team Lead ( FDA Regulations)


Dheepa joined I 3 Consulting in June 2014 bringing a wealth of Microsoft word, Excel & Paint processing experience to the team. As a Senior Consultant Dheepa methodically reviews and monitor projects allocated to junior consultants on a day-to-day basis to attain project timeline and quality parameters set. Before joining I 3 Consulting, Dheepa spent more than 2 years of her career as Management Representative for a company which manufactures Medical Devices as per EU and FDA regulations that helped her to gain knowledge in this domain.

Dheepa received her Graduation in Computer Science from Bharathiar University, presently settled with husband and child in Coimbatore. She spends leisure time in dancing and hearing songs.


Mrs. Mary Roopsy

Sr. Consultant & Team Lead


Roopsy joined I 3 Consulting in April 2017 as a Sr. Consultant. She has six years of Medical Device industrial experience from BPL, India and NMC, UAE. As a Team Lead Roopsy is charged with the ownership of CE and 510k projects which includes team management, status update and maintaining project timelines. She works on full energy and enthusiasm to see that each project is moving in the correct direction, technically and scientifically to ensure no non conformities arise from regulatory bodies post submission of dossiers.

Roopsy received her Graduation in Biomedical Engineering and Post Graduate Diploma in Clinical Engineering Management from MG university, presently settled with husband and children in Kochi. She spends free time volunteering at her church and spending time out doors with her family and friends.


Mrs. Deeksha Hegde

Sr. Consultant ( QMS & Product Certification)


Deeksha joined with us on October 2016 as a Junior Consultant bringing 4 years of past experience in Medical Device QA and RA documentation. Deeksha developed her skills and knowledge while working with manufacturing and consulting firms helped her promotion quickly as Senior Consultant. Presently she independently handles GMP, ISO 13485, 21 CFR 820, MDD Technical Files and Design Dossiers.

Deeksha graduated in Biotechnology from Nitte University, presently settled with husband in Mumbai. Outside of her work Deeksha spends time in arts and crafts and in reading.


Ms. Asha Johnson

Sr. Consultant (EU Product Certification)


Asha joined with I 3 Consulting in Oct 2016 as a Junior Consultant, bringing 4 years of past experience in Medical Device QA and RA documentation. She was promoted as Sr. Consultant in a short span. Presently she independly handles Clinical evaluation as per MEDDEV 2.7/1 Rev 4, Risk Analysis as per ISO 14971 and MDD Technical File Preparation.

Asha graduated in Biomedical Engineering from University of Calicut and completed M.S in Biomedical Engineering from New Jersey Institute of Technology, USA. She presently resides with family in Kochi. Asha spends free time in social networking and enjoying songs.


Mrs. Sonia Suresh

Sr. Consultant (FDA Regulation)


Sonia joined I 3 Consulting in June 2017, bringing 4 years of Industrial regulatory experience. As a Senior Consultant, her responsibilities include Food, Nutraceutical, Pharmaceutical, Medical Device & Cosmetic Label compliance as per US FDA Code of Federal Regulation.

Sonia B Tech in Biotechnology & Biochemical from Kerala University. She lives in Bangalore with her family and enjoys painting and singing.


Mr. Arun Francis

Sr. Consultant (MDQMS & GMP)


Arun joined I 3 Consulting in Sep 2017 as a Senior Consultant. Before joining the team he has more than 8 years of experience in Quality Management System maintenance in Medical Device Industries as per ISO 13485 AND 21 CFR 820 and also act as Management Representative. Presently Arun works independly with various clients directly for ISO 13485 & 21 CFR 820 Implementation to achieve successfully certification.

Arun graduated in computer science from Mangalore University. Arun settled in Kochi with his parents, wife and children. He spend time with his family and friends during weekends and holidays.


Mrs. Honey Thomas

Sr. Consultant (EU Product Certification))


Honey joined I 3 Consulting October 2016, bringing more than 2 years of teaching experience and 2 years of industrial experience related to Biomedical Engineering. Her education background and work experience helped her to bacome Sr. Consultant in short time. As a senior Consultant, her responsibilities include Clinical Evaluation documentation, Post Market Survilance and Post Market Clinical Foolow up guidance to client as per EU standard and guidence.

Graduated in Biomedical Engineering from Calicut University Post Graduated form Amirita Vishwa Vidyapeetham University in Biomedical engineering. She He currently lives in Trivendram with Humband and children. Outside the firm and free times honey do jogging and Crocheting.


Mrs. Jinal Desai

Sr. Consultant (EU Product Certification)


Passionate about a career in Quality Assurance and Regulatory affairs Jinal joined I 3 Consulting on February 2018 as a Junior Consultant. Prior to joining she gained a good knowledge in working with in process QA team by maintaining day to day QA documents. Presently Jinal works with team leads as part of GMP implementation projects and also independly works on Clinical Evaluation and Technical File development for CE Marking.

Jinal is a Pharmacy graduate from Gujarat Technological University and Post Graduate from Gujarat Forensic Sciences University. She is settled in Bangalore with husband. Outside of the work and holidays she enjoys spending time by reading, listening music and outing with family and friends.


Mrs. Renu Zachariah

Sr. Consultant (EU Product Certification))


Renu started her carrier as a faculty in Kuwait University followed by QC engineer in an Industrial chemical company. Later, year 2016 joined with our team and gained experiences in FDA labelling reequipments for U.S and EU MDD requirements for CE Marking. Presently her services are helpful for the company in resolving Notified Body queries regarding Clinical Evaluation as per MEDDEV 2.7/1 Rev 4.

Renu is a graduate engineer in Bio-technology and Bio-Chemical from Kerala University. Renu settled with family at Trivandrum and enjoys spending time with her family and friends.