GxP Auditing

Product Description

We provide full-scope Good Manufacturing and Distribution Practice Services to ensure your compliance with the relevant EU and CIS legislation. We provide consultancy on all aspects of GMP and additional QP-services.  * Services of Qualified Person* Third Party Service set up for batch release * Quality Systems set up and review * Writing of SOPs and other documents * Auditing - Preparations for GMP, GDP audits and inspections - Third party GMP audits of API manufacturers - GMP inspections arrangement from health authorities * Training

Inpharmatis

  • LV
  • 2018
    On CPhI since

Inpharmatis

  • LV
  • 2018
    On CPhI since

More Products from Inpharmatis

  • Pharmacovigilance services

    Product Pharmacovigilance services

    Services of EU QPPV, Local QPPVPharmacovilgilance System Set up and Review servicesICSR managementOn-going monitoring and signal managementLiterature surveillance servicesRisk managementReporting – Product Safety Update Reports (PSURs) – Periodic Benefit-Risk Evaluation Reports (PBRERs) – Development Safety Update Reports (DSURs) – Periodic Adverse Drug Experience Reports (PADERs) – Risk Management Reports (RMPs)Safety Data Exchange AgreementsPharmacovigilance Quality System, audits and inspections – Pharmacovigilance System Master File (PSMF) – Standard Operating Procedures (SOPs) – Internal and third party audits, mock-up inspections, CAPA writingTraining
  • Regulatory Affairs

    Product Regulatory Affairs

    Inpharmatis offers comprehensive regulatory affairs services to Life Science Industry including Drug Development and Vigilance Services to pharmaceutical, medical device, food supplements, cosmetic and biotech companies. Our area of expertise lies in the European & CIS market, however though our network of credible partners we are able to manage also US, Latin America and selected RoW procedures. A multi-disciplinary team of qualified regulatory affairs consultants is at your disposal for all aspects of your marketing authorisation applications for active substances and human medicinal products. Inpharmatis shall provide full regulatory support over the whole life cycle of your product. - Advise on regulatory submission strategy - Development of regulatory strategy for the product’s life cycle- Submission preparation / review, filing and management - Regulatory Strategy Consulting - Filing and product life cycle management
  • eSolutions

    Product eSolutions

    Our eSolutions services include consulting services in all areas of Regulatory Operations, e.g. transition to electronic submission, compliance with EU eSubmission Roadmap, submission process optimisation, implementation of efficient Regulatory Information Management (RIM), compliance with XEVMPD and IDMP requirements as well as other innovative topics in the framework of Regulatory Operations. Inpharmatis is the named partner of Extedo GmbH in the Baltics and CIS Region.

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