Employees - Antrix - Regulatory Affairs Quality Assurance Consulting Services and Products

RA / QA Team

Our team is committed to help medical device, pharmaceutical and biotech companies achieve their goals by delivering high quality safe and effective products.

Rupa Parekh
Principal

Rupa 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 Rupa 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. Ms. Rupa has extensively worked on clinical trials with oratech and MDS Pharma. She 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.

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 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.

Harry Kumar
Consulting Software Development Engineer

Mr. Harry has 10 years of software development and validation experience in the Medical Device, Pharmaceutical and High Tech private and public companies. Mr. Harry is responsible for driving Antrix’s software validation activity. Mr. Harry holds a BS in Computer Science from Univestiy of Gujara

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.