Polpharma Biologics (Rezon Bio)
Poland
Program data pending ClinicalTrials.gov matching
Profiled
Not yet scored
✓ FDA Inspections (1)
○ Clinical Trials
○ SEC Filings
○ Press
✓ EMA GMP (14)
○ MHRA GMP
✓ HC GMP (3)
Quick Facts: Polpharma Biologics (Rezon Bio)
- Signal Score
- Profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed. How scoring works
- Headquarters
- Poland
- Website
- https://rezonbio.com/
- Modalities
- Biologics
- Active Programs
- No ClinicalTrials.gov matches confirmed
- Data Sources
- FDA Data Dashboard, ClinicalTrials.gov, SEC EDGAR, press monitoring
About Polpharma Biologics (Rezon Bio)
Polpharma Biologics (Rezon Bio) is a contract development and manufacturing organization (CDMO). Capabilities: Biologics. 2 manufacturing sites registered with the U.S. FDA and Health Canada. Website: https://rezonbio.com/
Signal Score
Profiled, not yet scored.
Scores are published after regulatory evidence is attached and reviewed.
How scoring works
Polpharma Biologics (Rezon Bio) FDA Inspection History
2023-06
NAI
VAI
OAI
| Date | Site | Type | Observations | Classification |
|---|---|---|---|---|
| 2023-06-23 |
Polpharma Biologics S.A
Gdansk
Company-level
|
Drug Quality Assurance | No | Voluntary Action Indicated (VAI) |
Source: FDA Data Dashboard · Retrieved Oct 31, 2026
Polpharma Biologics (Rezon Bio) EMA GMP Compliance 14 certificates
2025-09
2025-09
2025-02
2025-02
2025-02
2023-06
2023-06
2023-05
2023-05
2022-09
2022-04
2021-05
2021-05
2020-11
Compliant
Non-Compliant
| Certificate | Site | Country | Inspection Date | Status |
|---|---|---|---|---|
| ISF.405.146.2025.IP.1 WTC/0583_01_01/315 | Polpharma Biologics S.A. | Poland | 2025-09-26 | COMPLIANT |
| ISF.405.146.2025.IP.2 WTC/0583_01_02/316 | Polpharma Biologics S.A. | Poland | 2025-09-26 | COMPLIANT |
| ISF.405.31.2025.IP.1 WTC/0622_01_01/63 | Polpharma Biologics S.A. | Poland | 2025-02-07 | COMPLIANT |
| ISF.405.31.2025.IP.2 WTC/0622_01_01/64 | Polpharma Biologics S.A. | Poland | 2025-02-07 | COMPLIANT |
| ISF.405.31.2025.IP.3 WTC/0622_01_02/65 | Polpharma Biologics S.A. | Poland | 2025-02-07 | COMPLIANT |
| ISF.405.18.2023.IP.1 WTC/0583_01_01/185 | Polpharma Biologics S.A. | Poland | 2023-06-23 | COMPLIANT |
| ISF.405.18.2023.IP.2 WTC/0583_01_02/186 | Polpharma Biologics S.A. | Poland | 2023-06-23 | COMPLIANT |
| ISF.405.2.2023.MP.1 WTC/0622_01_01/163 | Polpharma Biologics S.A. | Poland | 2023-05-26 | COMPLIANT |
| ISF.405.2.2023.MP.2 WTC/0622_01_02/164 | Polpharma Biologics S.A. | Poland | 2023-05-26 | COMPLIANT |
| IWSF.405.127.2022.IP.1 WTC/0583_01_01/279 | Polpharma Biologics S.A. | Poland | 2022-09-08 | COMPLIANT |
| IWSF.405.81.2022.IP.1 WTC/0622_01_01/189 | Polpharma Biologics S.A. | Poland | 2022-04-07 | COMPLIANT |
| IWSF.405.71.2021.IP.1 WTC/0583_01_01/192 | Polpharma Biologics S.A. | Poland | 2021-05-14 | NON-COMPLIANT |
| IWSF.405.71.2021.IP.2 WTC/0583_01_02/193 | Polpharma Biologics S.A. | Poland | 2021-05-14 | NON-COMPLIANT |
| IWPS.405.7.2021.AL.1-1 WTC/0583_01_02/31 | Polpharma Biologics S.A. | Poland | 2020-11-19 | NON-COMPLIANT |
Source: EMA EudraGMDP · Retrieved Oct 31, 2026
Hiring Activity 12 open roles Beta
From public job postings on Polpharma Biologics (Rezon Bio)'s careers board, as of Oct 30, 2026. Job postings are signals, not statements by the company; each one below links to the original. How we collect this
12
open roles
2
in manufacturing, quality, PD/MSAT, engineering or regulatory (17%)
Trend from Nov 29, 2026
Tracking started Oct 30, 2026. 30-day change shows after 30 days, 90-day after Jan 28, 2027.
By function
By site
Duchnice
1 mfg/ops · 1 PD/MSAT · 7 other 9
1 mfg/ops · 1 PD/MSAT · 7 other 9
Gdańsk
· 3 other 3
· 3 other 3
Latest postings
Upload Your CV for Future Roles
Other (finance, HR, IT, other) · Duchnice
USP Development Scientist (Duchnice)
Process development & MSAT · Duchnice
TechnikTechniczka Higieny (na produkcji leków)
Other (finance, HR, IT, other) · Duchnice
TechnikTechniczka Higieny (na produkcji leków)
Other (finance, HR, IT, other) · Duchnice
Prześlij swoje CV dla przyszłych projektów rekrutacyjnych_
Other (finance, HR, IT, other) · Duchnice
People and Organization Business Partner (Gdańsk)
Other (finance, HR, IT, other) · Gdańsk
People and Organization Business Partner (Gdańsk)
Other (finance, HR, IT, other) · Gdańsk
Operatorka Produkcji Ssaczej (absolwenci) BiotechnologiaChemiaFarmacjaBiologia (km)
Manufacturing & operations · Duchnice
Network Engineer Team Leader
Other (finance, HR, IT, other) · Gdańsk
Naukowiec Rozwoju Procesu USP (kmd) (Duchnice)
Other (finance, HR, IT, other) · Duchnice
Join our Quality Department!
Other (finance, HR, IT, other) · Duchnice
Dołącz do zespołu Jakości w Duchnicach!
Other (finance, HR, IT, other) · Duchnice
Coverage: counted from Polpharma Biologics (Rezon Bio)'s own careers board.
Function groups come mainly from job titles (about 84% match a hand check), and modality words from titles only, so both are approximate.
Source:
careers.rezonbio.com
· Checked Oct 30, 2026 · Tracking since Oct 30, 2026
Frequently Asked Questions About Polpharma Biologics (Rezon Bio)
How many FDA inspections does Polpharma Biologics (Rezon Bio) have on record?
CDMO Signal tracks 1 FDA inspection for Polpharma Biologics (Rezon Bio), sourced from the FDA inspection database. See the full inspection history above.
Has Polpharma Biologics (Rezon Bio) received an FDA warning letter?
CDMO Signal has no FDA warning letters on record for Polpharma Biologics (Rezon Bio).
Does Polpharma Biologics (Rezon Bio) hold EMA or MHRA GMP certificates?
CDMO Signal tracks 14 EMA GMP certificates for Polpharma Biologics (Rezon Bio).
Does Polpharma Biologics (Rezon Bio) have a CDMO Signal Score?
Not yet. Polpharma Biologics (Rezon Bio) is profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed.
Evaluating Polpharma Biologics (Rezon Bio) for a manufacturing program?
Use the free AI matchmaker to compare Polpharma Biologics (Rezon Bio) against other CDMOs by FDA, EMA, and clinical-trial data — no login required.
Find & compare CDMOs →
Represent this organization? Contact us to verify or update this profile.
See all CDMOs in:
Similar CDMOs
Pfizer CentreOne
Kalamazoo, MI · McPherson, KS
Signal Score: 87.7
Biologics, mRNA
FUJIFILM Diosynth Biotechnologies
Research Triangle, NC · Holly Springs, NC · Hillerod, DK
Signal Score: 84.8
AAV, mRNA/LNP, Biologics, mRNA, Microbial Fermentation, Recombinant Protein
Ajinomoto Bio-Pharma Services
San Diego, CA · Osaka, JP
Signal Score: 83.5
Oligonucleotide, Biologics, AAV
Piramal Pharma Solutions
Lexington, KY · Riverview, MI · Ahmedabad, IN
Signal Score: 83.5
Biologics, ADC
Richter BioLogics
Hamburg, Germany
Signal Score: 82.9
Plasmid DNA, Recombinant Proteins, VHH/Nanobodies, Bacterial Vaccines, Biologics, Microbial Fermentation
Compare Polpharma Biologics (Rezon Bio) with another CDMO
Side-by-side scoring, FDA inspection history, EMA/MHRA GMP coverage, and clinical-program footprint.