About Us

We provide practical solutions that cover all stages of a product’s life cycle from consumer insight, ingredient innovation, testing to technical consultancy and global regulatory advice. We have an intensely collaborative strategy creation process, with client personnel and XPLORE team members seamlessly interacting and ultimately converging on strategy recommendations.

Our team is harnessed to the latest updates and withstands huge capability in creating valuable facets, with a great experience of industry, creating a valuable package with utmost precision.

XPLORE healthcare bring forth content and service which is tailored to a client requirements and specifications.

VALUABLE INSIGHTS:

Xplore Healthcare Solutions has deep consulting expertise across many industries (Medical Devices, Pharma, Biotech/Biosimilars, Nutraceuticals/Food and OTC). Working alongside clients on their most critical challenges often results in new industry perspectives and insights. Our top regulatory experts optimize submissions, ease filings and keep you ahead. XPLORE comprises some of the most experienced and adept minds with over 35+ years of experience in regulation.

QUALITY:

Quality of product is not a destination but a journey. Focus and commitment to quality has to be incorporated into everyday operation at every level in your Medical device, IVD, Pharmaceutical, Nutraceutical company to truly produce quality products and consistently meet the various mandatory requirements of ISO 13485:2016, FDA QSR, USFDA, ANVISA, MDSAP or any other applicable standard.

While many medical devices and pharmaceutical companies understand the importance of a Quality Management System (QMS), Good Manufacturing Practices (GMP), but often the QMS, GMP that is set up internally is widely different from the actual practices. This is a gap that Xplore Healthcare Solution LLP has been addressing and has been facilitating in obtaining complete compliance and ISO 13485:2016, ISO 9001:2015 and MDSAP certifications that in a true sense prove to be a value addition in the long term for companies.

We provide customized quality system SOPs and forms, and generate product and process specific documents to help obtain certifications.

Service ranges from reviewing and upgrading the quality management systems to comprehensive oversight of vendors, systems, manpower and regulatory certification. The highly experienced personnel’s offer fast, efficient and accurate consultancy, providing precise support to reach beyond industry standards.Xplore Healthcare Solution LLP’ involvement can help you streamline your processes and set up optimized efficient systems with well-defined responsibilities and accountability.

CONFIDENTIALITY:

Xplore Healthcare maintains a confidentiality relationship between two parties. We value Client’s confidentiality and ensure it is kept intact at all times.

SUCCESSFUL TRACK RECORD

We have enjoyed working with more than 200 Medical Device, Pharma and Nutraceuticals giants and have succeeded to serve them efficiently. We have an established track record, with a number of references. To help our clients understand the regulatory and audit inspection expectations, we have been consistently leveraging our learning and experience with regulatory bodies like the FDA, Health Canada, Australian TGA, and European Notified Bodies like TUV, SGS, BSI, MedCert, UL, DQS, GMED, and others.

RESPONSIVENESS

XPLORE are great listeners. Before the inception of any project, we work with our clients to cover every aspect of work assigned. Dedicated personnel are assigned to have constant surveillance and monitoring of the project. Our team believes in being proactive as opposed to reactive. We foresee looking into the big picture and can spot and correct areas of concern well before they become a problem. We not only know how to find causes of regulatory issues, but we also know where they typically occur. Most importantly, we know how to formulate a strategy to correct them. XPLORE believes that Clients, big or small, public or private, can benefit from an innovative platform through which sophisticated regulatory advice can be delivered cost-effectively without any compromise on quality and expertise.