– Development of Quality documentation
– GAP analysis and GMP auditing
– GAP analysis and GDP auditing
– Training
Audited EU Pharmacovigilance System, QPPV Services, PSMF, PSURs, RMP development, Development and implementation of Quality System, Audits, eSubmissions and training.
Official Extedo Representative of Extedo GmbH: leader in eSubmission software development for RA and PhV.
– Used by more than 70% of Health Authorities in the world
– Preparation of eSubmissions for Clients in eCTD and other formats
Inpharmatis offers comprehensive Regulatory Affairs, Drug Development and Vigilance services to pharmaceutical, medical device, cosmetic and biotech companies.
Our area of expertise lies in European market, however though our network of credible partners we are able to manage also CIS, US, Latin America and selected RoW procedures.
Would you like one of our training courses delivered at a time and location to suit you? Would you like us to develop a course to meet your Team’s requirements? Address your Team’s specific needs with a tailored training approach!
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.
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Rephine Balticum provides 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.
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.
Rephine Balticum eSolutions services include consulting services in all areas of Regulatory Operations, e.g. transition to electronic submission, compliance with EU eSubmission Roadmap, submission process optimization, 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.
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 authorization applications for active substances and human medicinal products. We shall provide full regulatory support over the whole life cycle of your product.
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
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.