Medra+ is a Regulatory Affairs and QA consultancy firm, with proven expertise and skills for the last 20 years in the field of Global Regulatory Affairs of medical devices, IVD’s, drugs & pharmaceutical products, cosmetics, etc.,
Medra+ serves clients across Singapore, Malaysia, Brunei, Vietnam, Thailand, Taiwan, Indonesia, Philippines, Myanmar and United States fulfilling all their regulatory requirements needed and acts as a solution provider for clients by completing the following services, which include:
- Technical File Writing Services for CE mark and FDA approval
- QMS compliance consultancy (ISO 13485/SS620 / GDPMD / GLP / PIC/S GMP, WHO – GMP, cGMP/ISO 15189/ISO9001/ MDR/IVDR/21 CFR 820/GDP)
- Product registration in Asia, Europe and USA
- Regulatory Consulting / Strategy Development
- Design and Development and R&D compliance document preparation
- Support & Clients During Regulatory Audits (including Pre-Audit Preparation)
- Outsourcing – Regulatory Affairs and QA Works
Why MedraPlus.?
Medra+ has developed multiple global strategies for various products across the globe which support the client by expanding into international markets outside their home base. The aim is to help the clients achieve their sales in a very cost-effective way by accomplishing all the regulatory compliances.
Experienced Consultant Team
We have strong team expertise in supporting all regulatory affairs and QA activities. Co-operating with the client to the last mile. Actively, monitor and maintain the status of each process to proceed regulatory approvals
Deliverables on committed timelines
The main moto of Medra+ is to adhere to the committed timelines by active team formation, allocating separate work schedules among the team, frequent follow up on the progress at each stage.
Flexibility towards the customers
Work commencement after clear understanding of the clients requirement and provide quality training through personal interaction, online meetings and conference calls.
Cost Effective
Medra + provides Value for money proposition by offering quality work and best competitive price in the market.
World-wide Registration
MEDRA+ offers IVD and General medical product registration to clients who want to sell products in the ASIA, USA and European region. Medra+ has successfully registered products of more than 150 companies allowing our clients to enter into their target markets nearly 958+ products.
Continuous follow-up and Support
Medra+ does frequent interaction, follow-up, and updation about the process to the client through various mediums of communication. Customized WhatsApp group for every client to facilitate quick response to achieve the successful end result.