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 assists clients in navigating the complexities of regulatory affairs, pharmacovigilance, and medical consultancy for human and veterinary medicines, medical devices, and food supplements. They emphasize collaboration with EU national competent authorities and the EMA to simplify the path to market excellence.
**Expertise & scope**
* Regulatory Affairs
* Pharmacovigilance
* Medical Consultancy
* Medical Affairs
* Quality/GxP
* Digital Consultancy
* Medical Devices and In Vitro Diagnostics
* Regulatory and Scientific Communication
* Human Medicines
* Veterinary Medicines
**Reputation / proof points**
* Works with all EU national competent authorities and EMA.
* Focuses on expert guidance and strategic insights to propel projects forward with precision.
Billev Pharma East is a consultancy firm that assists clients in navigating the complexities of regulatory affairs, pharmacovigilance, and medical consultancy for human and veterinary medicines, medical devices, and food supplements. They emphasize collaboration with EU national competent authorities and the EMA to simplify the path to market excellence.
**Expertise & scope**
* Regulatory Affairs
* Pharmacovigilance
* Medical Consultancy
* Medical Affairs
* Quality/GxP
* Digital Consultancy
* Medical Devices and In Vitro Diagnostics
* Regulatory and Scientific Communication
* Human Medicines
* Veterinary Medicines
**Reputation / proof points**
* Works with all EU national competent authorities and EMA.
* Focuses on expert guidance and strategic insights to propel projects forward with precision.
Additional information
Billev Pharma East highlights the autonomy of Member States in organizing health insurance systems and allocating healthcare resources, as per Article 168(7) of the Treaty on the Functioning of the European Union. They note that national decisions on pricing and reimbursement must align with the free movement of goods principles and adhere to the Transparency Directive 89/105/EEC. This directive ensures pharmaceutical companies receive timely, motivated, and appealable decisions. Billev Pharma East's expertise helps clients manage national specificities alongside EU-wide regulatory compliance for successful market access.
Key Highlights
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Offers comprehensive services including Regulatory Affairs, Pharmacovigilance, Medical Consultancy, and support for Medical Devices and In Vitro Diagnostics.
Source
“Regulatory Affairs Pharmacovigilance Medical Consultancy Medical Affairs Quality/GxP Digital Consultancy Medical Devices and In Vitro Diagnostics”
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Collaborates with EU national competent authorities and the EMA.
Source
“We are working with all EU national competent authorities and EMA.”
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Provides expert guidance to simplify the path to regulatory excellence.
Source
“Our mission is to assist our clients in discovering the power of collaboration and, with the help of a team of trustworthy experts, simplify the path to excellence.”
Certifications & Trust Signals
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Based in Slovenia, serving the EU market.
Source
“Billev farmacija vzhod, d. o. o.Billev Pharma East Ltd.Tržaška cesta 202 1000 Ljubljana Slovenia”
Buyer Snapshot
Best for
- Companies seeking expert guidance in regulatory affairs and pharmacovigilance.
- Businesses navigating EU market access for medicines and medical devices.
How engagement typically works
- Collaborative approach with clients.
- Focus on strategic insights and precision.
Typical deliverables
- Regulatory strategy development.
- Pharmacovigilance system setup and management.
- Medical device compliance support.
- Consultancy on pricing and reimbursement.
Good to know
- Best when clients require EU-specific regulatory support.
HQ:
Sofia, SI
Languages:
English, Bulgarian
Timezones:
Europe/Sofia
Claim 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
Class I, IIa, IIb, III (implied by Medical Devices and In Vitro Diagnostics services)
Supports MDR
Yes
Supports IVDR
Yes
PRRC Qualification Summary
The website mentions individuals with qualifications such as M.Sc. Pharm. (Managing Director, QP/RP) and Doctor (Medical and Pharmacovigilance Lead/Medical Advisor/EU QPPV), indicating relevant expertise for PRRC roles.
Regulatory Experience
Not explicitly stated in years, but extensive experience implied through services offered and collaboration with EU authorities.
