Liv PQMS

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Liv PQMS

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    • Home
    • Services
    • Audits
    • Regulatory Compliance
    • FAQ
    • Contact Us
  • Home
  • Services
  • Audits
  • Regulatory Compliance
  • FAQ
  • Contact Us

Regulatory Compliance

The pharmaceutical industry is highly regulated, and navigating the complex regulatory landscape can be challenging. At LivPQMS, we provide comprehensive pharmaceutical regulatory consulting services to help you achieve compliance and bring innovative products to market safely and efficiently.

Our Services

 Liv PQMS is your trusted partner in navigating the intricate world of pharmaceutical regulatory consulting. We offer comprehensive and tailored solutions to help you achieve seamless compliance and bring your product to market with confidence. 

Our services include:

  • Regulatory strategy for new  product introduction
  • Expert guidance throughout the regulatory submission process
  • Technical documents (Product Dossier) preparation for product (drugs, Food, Cosmetic, Medical devices) registration in various countries all over the world.
  • We can act as your authorized Indian agent and representative, and will get sorted all the licensing, filings and approvals needs for easy penetration in to Indian market. 
  • eCTD & CTD dossier preparation
  • DMF compilation in CTD Format / Country Specific format  
  • Life-cycle management of Drug master File (DMF) 
  • Post-market surveillance compliance
  • Training and education
  • Preparation of FDA 483 and warning letter responses
  • Warning Letter and Consent Decree Remediation
  • Preparing the management for FDA meetings.

We also provide:

  • Independent, contract GxP audit services to assess your organization's compliance with Good Practices (GxP) regulations.
  • Regulatory training and workshops to help your team stay up-to-date on the latest regulatory requirements.

Regulatory Expertise

We boast a team of highly skilled regulatory consultants with in-depth knowledge and extensive experience in the pharmaceutical industry. Our consultants stay abreast of the latest regulatory developments and maintain close relationships with regulatory agencies, ensuring you receive the most up-to-date guidance.

Our Commitment to You

We are committed to providing our clients with the highest quality of service and support. We are responsive to your needs and will work with you to develop a customized regulatory strategy that aligns with your specific goals and timelines.

Contact Us

If you are looking for a trusted partner to help you navigate the pharmaceutical regulatory landscape, please contact us today. We would be happy to discuss your needs and how we can help you achieve your regulatory goals.

Learn more

Together, we can bring your vision to life.

FAQ

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