• • REGULATORY AFFAIRS

    We offer 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
    

    • Active Pharmaceutical Ingredients
      – ASMF development
      – FDA & EDQM lodgment services
    • Finished Medicinal Products
      –  Biologicals
      – Biosimilar
      – Biotech products and advance therapies
      – Orphan drug products
      – NCEs
      – Generics, bibliographical and herbals

    Development of regulatory strategy for the product’s life cycle

    • Consideration of international regulatory requirements
    • Regulatory classification of products across different jurisdictions
    • Provide expert regulatory CMC compliance advice throughout development
    • Work with Sponsors and regulatory authorities through the resolution of complex development issues
    • Act as an EU Agent in Europe, Nominated Local Representative for CIS submissions
    • Assist with due diligence activities for investors/licensees
    • Assistance in establishing necessary systems for market entry
      – Registration of legal entities for marketing authorisation applicants
      – GMP consulting and organization of inspections
      – Batch release and testing arrangements
      – Services of Qualified Person
      – Pharmacovigilance Systems & Services of QPPV
      – Government Access Consulting
    • Revision of plans in accordance to the changed guidelines
    • Development of SOPs & Management Systems

    Submission preparation / review, filing and management

    • Submission preparation and management throughout the whole pre-approval procedure
    • Pre-submission meetings
    • Post-approval submission management (preparation & filing variations, line extensions, renewals, re-classification submissions, PSURs and RMPs)
    • Labelling management
    • Scientific and Medical Writing Services
    • Reimbursement applications and management
    • Local representation
    • eSubmission Services

    Regulatory Strategy Consulting

    • Classification of your product (portfolio) according to national requirements (Class I, IIa, IIb, III)
    • Filing strategy in different markets, clinical trial requirements
    • Development of the technical documentation
    • Risk assessment
    • Guidance on conformity assessment procedure
    • Medicinal products with medical device components

    Filing and product life cycle management

    • Establishing and running vigilance systems
    • Local safety officer services
    • European / CIS representative services
    • SOPs writing
    • Training services

    Cosmetic Products

    • Product classification (including borderline products)
    • Product labeling in different languages and labelling management
    • Development of Product Information File
    • Safety Assessment
    • Function of Responsible Person in EU and Local Representative in CIS
    • Notification in the EU CPNP system
    • Registrations in CIS
    • Full Cosmetovigilance services

• • PHARMACOVIGILANCE

    Entrust your pharmacovigilance concerns in the experienced hands of our Team. Whether you need an urgent solution for an unexpected problem or are seeking to outsource entire pharmacovigilance processes – our knowledgeable consultants will be there for you.

    • Services of EU QPPV, Local QPPV
    • Pharmacovilgilance System Set up and Review services
    • ICSR management
    • On-going monitoring and signal management
    • Literature surveillance services
    • Risk management
    • Reporting
      – 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 Agreements
    • Pharmacovigilance Quality System, audits and inspections
      – Pharmacovigilance System Master File (PSMF)
      – Standard Operating Procedures (SOPs)
      – Internal and third party audits, mock-up inspections, CAPA writing
    • Training

• eSUBMISSIONS

  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.

  We are the named partner of Extedo GmbH in the Baltics and CIS Region.

  • Full eSubmissions Services for pharmaceutical and medical device companies
    • Europe (CP, MRP, DCP, national and maintenance)
    • FDA
    • Health Canada
    • Swiss Medic
    • Others
  • eCTD Support for Active Substance Master Files
  • Document templates
  • Implmentation of eSubmission tools:
    • eCTDManager
    • PcVManager
    • Document Management Systems

  GMP/GDP AUDITING

  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. This is an external “Qualified Person” (QP) – that is a competent person who carries out the regular work and takes responsibility in accordance with § 14 AMG on a freelance basis.

  • 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

  IN-HOUSE TRAINING

  Our in-house training can provide you with the flexibility you need whilst providing value for money.
  There are several options available if you wish to access our in-house training:
  

  1. Off the shelf: choose from our range of available programs
  2. Tailored: have one of our current courses tailored to suit your programme’s specific needs
  3. Find solutions to real problems by incorporating your own case studies and examples
  4. Bespoke: let us develop and deliver the course unique to You, based on the analysis of Your requirements

  In 2016 the most popular in house trainings have been on Introduction to RA in EU and CIS countries, Filing Variations in EU, Sales Skills for medical representatives

  Scientific and Medical Writing Services

  Our team of experienced medical writers would ensure the preparation and review of your existing medical documents and reports in order to achieve regulatory success.

  • Services of Quality, Non-Clinical, Clinical and Pharmacovigilance Experts
  • Quality Overall Summaries
  • Bibliographic applications
  • Environmental Risk Reports
  • PIL Readability Testing
  • Rx to OTC Switches
  • Government Access / Reimbursement applications
  • Quality System and SOP writing

   

  For more details or initial consultation, please contact our Team.

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