About Us - Antrix Regulatory Affairs Quality Assurance Consulting Services and Products

About Antrix

Antrix is highly respected consulting organization serving medical devices, pharmaceutical, and biotech industries for international quality and regulatory compliance strategy, implementation, validation and training.

Vision

Our vision is to be the leading provider of quality and regulatory consulting services to our customers who in turn help improve people's life by delivering safe and effective medical device and drugs.

Mission

Our mission is to provide high quality effective consulting services in order to

Maximize your success for fast domestic and international regulatory compliance (USA, EU, Japan, Canada etc.)
Minimize the issues, time and cost you may face with compliance system setup, FDA, notified body, competent authorities, local authorities etc.
Optimize the performance of your quality and compliance system through effective electronic implementation of ISO 9001, ISO 13485, QSR, GMP, ISO 14971 and best practices within the industry.

Team

Usha Kurani - CEO and President

Usha is detail – oriented, responsible, self-motivated, flexible, dedicated, efficient, reliable, creative individual. Strong organizational; communication skills and ability to work independently without supervision and team player. Ms Usha has ability to lead the organizational team to successfully manage the complete project. Excellent problem determination and solving skills, Worked on variety of medical device and drug product design, development, testing, process validation and launch. Worked on successfull commercialization of several new products like Celiac, ENA, ANA, Neural Zoomer, Food Allergy, Inhalent Allergy, Lyme Diesease, Ms. Usha has extensively worked on clinical trials with Oratech, MDS Pharma. At Vibrant and IVD company she setup ISO 13485, CLIA and CAP. She got successful certificatin for ISO 13485, CLIA and CAP. QMSShe helped analyze and did statistical analysis of many clinical trials conducted by the MDS Pharma used by its customers as CRO. Performed review and analysis on every aspect of the medical device and drugs manufacturing process before approval and launch helping companies deliver robust products. Helped launch successfully commercial products adhering to FDA and ISO 13485 regulations.

Shilpa Mydur - Regulatory Consultant

A health -enthusiast with a decade of regulatory experience. Most recently, I led a team at Glooko that achieved a hat trick of timely and successful FDA clearances by navigating the uncertain terrains of the mobile medical apps arena.
My regulatory background includes working knowledge of current FDA regulation and US regulatory submissions such as IDE, 510(k), Developing product labels and labeling, Review of literature searches, Quality System Regulation (21 CFR 820) and Quality management systems (ISO 13485:2003)
Additionally, I have in-depth Quality Engineering Experience (Statistical analysis of data, knowledge of Risk Management techniques (IS0 14971), HACCP, BOM development, Process validation) and Quality Compliance Experience (SOP development, NCMR, CAPA investigation).
I take great pride in volunteering as a Health Coach and a physician outreach specialist at the South Asian Heart Center, El Camino Hospital, California

Helen Teichman
Chief Pharmaceutical Associate

Helen Teichman offers the Pharmaceutical and allied industries her practical experience, technical knowledge, and powerful leadership skills to help them develop global strategies and implement tactical solutions in an environment of rapid change. She specializes in electronic document management and the eCTD.

Helen has worked as a regulatory affairs professional for 20 years. She spent many years with the Johnson & Johnson family of companies at which she held senior management positions in Canada, the U.S and Europe.

Helen was posted at the Janssen Research Foundation in Beerse, Belgium as Senior Director, International Regulatory Affairs & Global Operations. At Janssen, Helen was the enterprise-wide business leader for the implementation of document management technology and processes. This activity spanned two sites, U.S. and Europe, as well as the integration of operating company activities.

After Johnson & Johnson, Helen, joined a Washington-based management consulting firm as Vice President, Pharmaceutical. There she specialized in strategic and process-related consulting for the pharmaceutical industry. Helen has carried out numerous assignments in these areas at all scales- from promising start-up companies to established multi-national enterprises.

RA/QA Expert Consulting Advisors

Antrix has several RA/QA Expert Consulting Advisors like Rupa Shah - Clinical Affairs, Asha Parekh - Quality who work on variety of projects. Some of the projects they execute are listed below:
ISO 13485, FDA 820.30 QMS Implementation
Regulatory Pathways and Strategy for Medical Device Products
Medical Device Design and Process Verification and Validation
Complaint Handling
ISO and FDA Audits etc.

Murray Teichman
Marketing Communications and Graphic Designer Associate

Mr. Teichman specializes in marketing communications and graphic design. Mr. Murray is responsible for managing and maintaining the FrontEnd DocTemplates and eCTDirect Tools, Templates and Procedures including training people on how to use them.