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 provides expert regulatory affairs, pharmacovigilance, and medical consultancy services for human and veterinary medicines, and medical devices. They focus on simplifying the path to excellence for their clients by collaborating with EU authorities.
**Expertise & scope**
* Regulatory Affairs
* Pharmacovigilance
* Medical Consultancy
* Medical Affairs
* Quality/GxP
* Digital Consultancy
* Regulatory Affairs and In Vitro Diagnostics
* Regulatory and Scientific Communication
* Human Medicines
* Veterinary Medicines
* Pricing and Reimbursement strategies within the EU, aligning national decisions with EU principles.
**Reputation / proof points**
* Works with all EU national competent authorities and EMA.
Billev Pharma East provides expert regulatory affairs, pharmacovigilance, and medical consultancy services for human and veterinary medicines, and medical devices. They focus on simplifying the path to excellence for their clients by collaborating with EU authorities.
**Expertise & scope**
* Regulatory Affairs
* Pharmacovigilance
* Medical Consultancy
* Medical Affairs
* Quality/GxP
* Digital Consultancy
* Regulatory Affairs and In Vitro Diagnostics
* Regulatory and Scientific Communication
* Human Medicines
* Veterinary Medicines
* Pricing and Reimbursement strategies within the EU, aligning national decisions with EU principles.
**Reputation / proof points**
* Works with all EU national competent authorities and EMA.
Additional information
Billev Pharma East emphasizes a collaborative approach, leveraging a team of trustworthy experts to streamline regulatory processes. They are adept at navigating the complexities of national specificities within the EU while ensuring compliance with EU-wide regulations. Their services are tailored to propel projects forward with precision, aiming for successful market access and sustainable healthcare contributions. Clients can expect expert guidance and strategic insights to manage dual challenges of national autonomy and EU regulatory compliance.
Key Highlights
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Offers comprehensive solutions for product development, regulation, pharmacovigilance, quality system management, and regulatory informatics.
Source
“At Billev Pharma East, we offer comprehensive solutions for product development, regulation, pharmacovigilance, quality system management, and regulatory informatics.”
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Collaborates with EU national competent authorities and the European Medicines Agency (EMA).
Source
“We are working with all EU national competent authorities and EMA.”
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Provides expert guidance to manage dual challenges of national specificity and EU-wide regulatory compliance.
Source
“By relying on our expertise, pharmaceutical companies can effectively manage the dual challenges of national specificity and EU-wide regulatory compliance”
Certifications & Trust Signals
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Works with EU national competent authorities and EMA.
Source
“We are working with all EU national competent authorities and EMA.”
Buyer Snapshot
Best for
- Companies seeking expert regulatory affairs and pharmacovigilance support in the EU.
- Organizations needing assistance with medical device regulations (MDR/IVDR).
How engagement typically works
- Collaborative partnership
- Expert guidance and strategic insights
Typical deliverables
- Regulatory strategy development
- Pharmacovigilance system setup and management
- Medical device compliance support
- Consultancy on pricing and reimbursement
Good to know
- Best when operating within the EU market.
HQ:
Sofia, SI
Languages:
English, Bulgarian
Timezones:
Europe/Sofia
Claim status:
Listed
Services & Capabilities
Find PRRC Services | EU MDR/IVDR Providers & 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 MDR/IVDR support)
Supports MDR
Yes
Supports IVDR
Yes
PRRC Qualification Summary
The website mentions individuals with roles such as Managing Director, QP/RP, and Medical/Pharmacovigilance Lead/Medical Advisor/EU QPPV, indicating a qualified team.
Regulatory Experience
The website implies extensive experience through its team of international experts and focus on EU regulations.
