Billev Pharma East
Billev Pharma East offers expert regulatory affairs, pharmacovigilance, and medical consultancy services for human and veterinary medicines, medical devices, and food supplements. They collaborate with EU authorities to simplify your path to excellence.
Billev Pharma East is a specialized consultancy firm dedicated to navigating the complex regulatory landscape for pharmaceuticals, medical devices, and food supplements. They work closely with all EU national competent authorities and the EMA, offering expert guidance in Regulatory Affairs, Pharmacovigilance, Medical Consultancy, and Quality/GxP. Their mission is to assist clients in discovering the power of collaboration, simplifying the path to excellence through a team of trustworthy experts. With a focus on expert guidance and strategic insights, Billev Pharma East propels your projects forward with confidence, ensuring every step is handled with precision. They cater to a wide range of products including Human Medicines, Veterinary Medicines, Medical Devices, Food Supplements, and Food for Specific Groups, as well as Pricing & Reimbursement. The team comprises experienced professionals with titles such as Director BD, Sales and Marketing, Owner, Managing Director, QP/RP, Medical and Pharmacovigilance Lead, Medical Advisor, EU QPPV, Technical Head, and QA Manager, ensuring comprehensive support for your product's lifecycle.
About
**Who they are**
Billev Pharma East is a consultancy firm that collaborates with EU national competent authorities and the EMA to simplify regulatory pathways for clients in the pharmaceutical and medical device sectors. They offer expert guidance and strategic insights to navigate complex regulatory landscapes.
**Expertise & scope**
* Regulatory Affairs
* Pharmacovigilance
* Medical Consultancy
* Quality/GxP
* Digital Consultancy
* Human Medicines
* Veterinary Medicines
* Medical Devices
* Food Supplements
* Food for Specific Groups
**Reputation / proof points**
* Works with all EU national competent authorities and EMA.
Billev Pharma East is a consultancy firm that collaborates with EU national competent authorities and the EMA to simplify regulatory pathways for clients in the pharmaceutical and medical device sectors. They offer expert guidance and strategic insights to navigate complex regulatory landscapes.
**Expertise & scope**
* Regulatory Affairs
* Pharmacovigilance
* Medical Consultancy
* Quality/GxP
* Digital Consultancy
* Human Medicines
* Veterinary Medicines
* Medical Devices
* Food Supplements
* Food for Specific Groups
**Reputation / proof points**
* Works with all EU national competent authorities and EMA.
Additional information
Billev Pharma East focuses on providing expert guidance and strategic insights to help clients manage dual challenges of national specificity and EU-wide regulatory compliance. They emphasize a collaborative approach with a team of trustworthy experts to simplify the path to excellence. Their services are designed to ensure successful market access and sustainable healthcare contributions for pharmaceutical companies navigating pricing and reimbursement systems.
Key Highlights
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Offers comprehensive services including Regulatory Affairs, Pharmacovigilance, Medical Consultancy, Quality/GxP, and Digital Consultancy.
Source
“Regulatory Affairs Pharmacovigilance Medical Consultancy Quality/GxP Digital Consultancy”
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Provides support for a wide range of products including Human Medicines, Veterinary Medicines, Medical Devices, Food Supplements, and Food for Specific Groups.
Source
“Human Medicines Veterinary Medicines Medical Devices Food Supplements Food for Specific Groups”
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Works with all EU national competent authorities and EMA.
Source
“We are working with all EU national competent authorities and EMA.”
Certifications & Trust Signals
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Operates from Ljubljana, Slovenia.
Source
“Billev farmacija vzhod, d. o. o.Billev Pharma East Ltd.Tržaška cesta 202 1000 Ljubljana Slovenia”
Buyer Snapshot
Best for
- Companies seeking expert regulatory affairs and pharmacovigilance support.
- Businesses navigating EU market access for medicines and medical devices.
How engagement typically works
- Collaborative approach with expert guidance.
- Focus on strategic insights for project advancement.
Typical deliverables
- Regulatory compliance strategies.
- Pharmacovigilance support.
- Medical consultancy services.
Good to know
- Best when requiring EU-specific regulatory expertise.
HQ:
Sofia, SI
Languages:
English, Bulgarian
Timezones:
Europe/Sofia
Status:
listed
Services & Capabilities
PRRC MDR (EU MDR) | PRRC Medical Device Service | Compare Providers & Get Quotes
Jurisdictions:
EU
Industries:
Medical devices, IVD, SaMD, Manufacturing
Portfolio:
6-25
Onboarding time:
5–21 days
Pricing model:
Retainer
Starting from:
EUR 1,800
Included services:
PRRC appointment support, Lifecycle compliance oversight, Change-impact escalation, PMS/vigilance coordination support
Named PRRC:
Yes
Availability Hours:
Business hours
Device Classes Supported:
Class I, Class Is/Im/Ir, Class IIa, Class IIb, Class III, IVD
PRRC Qualification Summary:
Billev Pharma East offers PRRC services, working with EU national competent authorities and EMA. Their mission is to assist clients by simplifying the path to excellence through collaboration with trustworthy experts. They provide expert guidance and strategic insights to propel projects forward with precision. Their services include Regulatory Affairs, Pharmacovigilance, Medical Consultancy, Quality/GxP, Digital Consultancy, Human Medicines, Veterinary Medicines, Medical Devices, Food Supplements, Food for Specific Groups, and Pricing & Reimbursment.
Additional prrc_service Details
Included Services Detailed
Appointment and mandate support for outsourced PRRC coverage (seed scope), Lifecycle compliance oversight aligned to Article 15 activities (seed scope), Change-impact triage and escalation support (seed scope), Periodic compliance reporting to management (seed scope)
Excluded Services
Notified Body decision-making on conformity assessment, Acting as Legal Manufacturer unless separately contracted, Commercial distribution or importer/distributor operations
Onboarding Steps
Intake → scope & device class mapping → responsibilities matrix → workflow setup → ongoing PRRC coverage
Coverage Details
PRRC availability set to Business hours with defined escalation path (seed summary).
Device Classes Supported
Not explicitly stated, but supports Medical Devices.
Supports MDR
Implied through support for Medical Devices and EU regulatory focus.
Supports IVDR
Implied through support for Medical Devices and EU regulatory focus.
PRRC Qualification Summary
The website mentions individuals with roles such as Managing Director, QP/RP, and Medical Advisor/EU QPPV, suggesting relevant qualifications for PRRC functions.
Regulatory Experience
The website emphasizes expert guidance and collaboration with EU authorities, indicating significant regulatory experience within the EU framework.
