Regulatory Services

Regulatory approvals are mandatory to legally sell. Given the complex regulatory framework that medical device and pharmaceutical companies (Healthcare and Life Sciences) need to work with, it is easy to make mistakes. This can result in delaying the market entry, ultimately resulting in incurring unnecessary costs. Xplore has helped medical device and pharmaceutical companies expand their businesses by partnering and executing end to end approval and clearance processes.

With the help of Xplore, you can pursue the most optimal regulatory path to approval, successfully complete the registration for your device, drugs product, and maintain compliance with worldwide applicable post-market requirements.

MEDICAL DEVICES: The most important element of getting your medical device approved is the implementation of a fundamental regulatory strategy and sound technical documentation. Our regulatory team provides you guidance and support to comply with the correct medical device regulation and market access requirements with a tailor-made service package we can provide excellent and efficient support in preparing access to global markets.

Explore our wide range of Medical Device, In-Vitro Diagnostics (IVDs), and Combination Device services, which will help you stay compliant with existing and changing regulatory and quality requirements

  • Sugam Portal submissions for CDSCO/DCGI
  • Preparation of Device Master File/technical documentation/Plant Master File
  • ISO 13485:2016 Certification
  • ISO 9001:2015 Certification
  • Lead / Internal Audits as per ISO 13485:2016, ISO 9001:2015, GMP and Compliance
  • Medical Device Registration and Approval in India with CDSCO (MD Form 5)
  • Medical Device Manufacturing License for Indian Manufacturer (MD Form6)
  • PMA Submission
  • MDD to MDR Implementation as per Indian MDR-17 & EU-MDR
  • Medical Device Registration in USA, Europe, (EUDAMED), Singapore, Brazil, Canada, India and rest of the world (ROW)
  • Regulatory Filing to USFDA like 510(k)
  • US agent and e-filing Support
  • CE marks and All EU Registrations
  • Other ROW Country Specific Submissions
  • Health Canada MDL and MDEL
  • Australian TGA approvals.
  • Medical Devices Registrations in USA, Europe (EUDAMED), Singapore, Brazil, Canada, India and Rest of World (ROW)
  • Investigational Device Exemption (IDE)
  • Emergency Use Authorization (EUA)
  • Review of marketing and advertising materials, publications.
  • Device and Plant Master File Preparation and Maintenance
  • Global Medical Device Approval and Registration
  • Risk Analysis and Risk Management for all Classes of Medical Devices and IVDs as per ISO 14971 requirements.
  • Clinical Evaluation as per Meddev 2.7.1 Rev. 4 and ISO 14155 requirements
  • Design Control Documentation and Design History File (DHF)
  • Sterilization Method Validation and Documentation as per ISO 11135, ISO 11137, ISO 17665 requirements
  • Clean Room Validation Documentation and Methods as per ISO 14644 series of Standards
  • Medical Device Packaging Validation Documentation Requirements and Method of Validation as per ISO 11607-1 and ISO 11607-2 requirements
  • Medical Device Post Market Surveillance and Vigilance Requirements
  • Software verification and validation as per CSV, 21CFR Parts
  • Post marketing surveillance, PMCF, Amendments, Supplements
  • Online or In House Training for Employees GMP, ISO, CAPA, 21 CFR, QMS, Risk Management.
  • Technical documentation market approval / release and access for the Indian, European and US market as well as global markets.
  • Regulatory Strategy
  • Liaison with Notified Body, Competent Authority, European Commission, USFDA and CDSCO
  • CE Marking Guidance
  • Prepare / Review Risk Analysis
  • Prepare / Review Essential Requirements
  • Instruction for Use / Labeling
  • Clinical Evaluation Report
  • Regulatory Training
  • Mock Regulatory Audits

Xplore’s global regulatory team can help you with all aspects of Nutraceutical regulation, whether that’s from conventional testing, a regulatory question or contributing to an internationalization strategy.

  • Global Regulatory advice.
  • Product compliance .
  • Label assessment.
  • Dossiers writing.
  • Regulatory review of concepts technologies and claims