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BCRS - Balkan Clinical and Regulatory Services Ltd.

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Sofia, BG

About BCRS - Balkan Clinical and Regulatory Services Ltd.

BALKAN CLINICAL & REGULATORY SERVICES (BCRS) is full-service Contract Research Organization (CRO), experienced in performing Drug Development activities and Human Biospecimen procurement in South East and Central Europe. BCRS's staff is conducting clinical research activities in this growing and dynamic... Show more »

BALKAN CLINICAL & REGULATORY SERVICES (BCRS) is full-service Contract Research Organization (CRO), experienced in performing Drug Development activities and Human Biospecimen procurement in South East and Central Europe. BCRS's staff is conducting clinical research activities in this growing and dynamic region of the world since 2007. Our regional focus, experienced Project Managers, involvement of upper management, and concentration on client satisfaction has helped us grow and enhance our services. Managed by a team of clinical research professionals with more than 65 years of combined industry experience, BCRS maximizes the benefits of the region with a complete understanding of all international clinical and research standards.

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Our Services (41)


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Human Plasma and Serum

Starting at $95.00 per sample

BCRS offers many Human Biological products for research and clinical purposes. We supply Human Whole Blood, Serum and Plasma. The samples contain blood products from healthy donors and from patients with malignant and benign diseases, autoimmune disorders, infections diseases, diabetes or other diagnoses if needed. We have a... Show more »

BCRS offers many Human Biological products for research and clinical purposes. We supply Human Whole Blood, Serum and Plasma. The samples contain blood products from healthy donors and from patients with malignant and benign diseases, autoimmune disorders, infections diseases, diabetes or other diagnoses if needed. We have a variety of samples containing infected with HAV, HBV, HBsAg, HCV, HIV1 and HIV2 blood with partial or complete clinical and demographic data.
Our team could offer you specific clinical research samples so please give us a chance to find out what your particular needs are.

All human blood products offered by us are collected at clinical and commercial sites from our network within South East Europe.
Each unit from healthy volunteer is tested and found negative for: HBsAg, HCV, HIV-1, HIV-2, HIV-1Ag or HIV 1-NAT, ALT, and syphilis in accordance with the international GLP standards.

GET 10% OFF your first order!

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Human Oncology Psychiatry/Mental Health Hematology Rare Disease CNS/Neurology Cardiovascular Dermatology Gastroenterology Infectious Disease Ophthalmology Respiratory Nephrology and Urology Pediatrics Metabolism and Endocrinology Neurology Gynecology Virology Rheumatology Endometrial diseases Sarcoma Acute Myeloid Leukemia (AML) Acute Lymphocytic Leukemia (ALL) Chronic Myelogenous Leukemia (CML) Chronic Lymphocytic Leukemia (CLL) Anemia Colorectal cancer Diabetes Neurodegenerative diseases Prostate Cancer Chronic obstructive pulmonary disease (COPD) Atherosclerosis Hepatitis B Hepatitis C Lung Cancer Alzheimers Disease Cystic fibrosis Asthma Ovarian Cancer Pancreatic cancer Liver cancer Bladder cancer Neuroblastoma Glaucoma Non-small cell lung cancer (NSCLC) Small-cell lung cancer (SCLC) Neuroendocrine Cancer Brain cancer Leukemia FFPE tissue Antibodies Blood Frozen Tissue Human tissue Biofluids Biopsy tissue Bone marrow Fresh Tissue Tumor tissue PBMC's Drug Discovery Antibiotic Development Neuroscience blood Show 64 more tags Show less

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Prospective Human Tissue Collection

Price on request

BCRS can provide you with tailor-made solution based on your custom collections that will meet your immediate research project needs.

The access that our company have to thousands of human tissue specimens is very client-satisfactory, but even with this number of samples, every once in a while we do get a challenging... Show more »

BCRS can provide you with tailor-made solution based on your custom collections that will meet your immediate research project needs.

The access that our company have to thousands of human tissue specimens is very client-satisfactory, but even with this number of samples, every once in a while we do get a challenging requests for specimens that we don’t have on stock. In these situations, we use our Custom/Prospective Collections to fulfill the needs of our clients.

We have good expertise at new collections, site recruitment, training, and monitoring due to our more than 15 years’ experience in clinical trials.

With our vast sites network of surgical, clinical and pathology departments, we are well positioned to design custom specimen collections for a huge variety of clinical indications and diagnosis. Our pathology team and other laboratory professionals can help in design and effective collection of the materials you need.
We have access to more than 80 university and municipal hospitals that would help your research needs.to get the specific samples for your project in a short time.
We have good expertise at new collections, site recruitment, training, and monitoring due to our more than 15 years’ experience in clinical trials.

With Custom Collections, BCRS is able to provide the following services:
For your custom collection in addition, we can provide you with:
• Estimated accrual rates based on your collection needs
• Logistic analysis of collection, processing, and shipment to minimize cost
• Custom development of Informed Consent Forms (if necessary)
• Custom-design protocol development (if necessary)
• Project Management from specimen collection to delivery
• Includes site monitoring, timeline coordination, and troubleshooting.
• Follow-up study support
• Diagnosis through treatment, and the outcome.
• Relapse and information about surgery or change of treatment
• All collections include standard or custom clinical data as sex, race, age, type of diseases, diagnosis, sub diagnosis, classification etc.

With Prospective Custom Collections, we can collect blood and blood products, tissue samples – fresh, frozen or fixed, and other bio-fluids from a rapidly growing network of sites, including the biggest public university hospitals chains in Bulgaria, Chez Republic, Serbia, Montenegro, Hungary, Romania, Croatia, Slovenia, Macedonia, Russia with clinics in Urology, Nephrology, Neuro-Surgery, Gastroenterology, Cardiology, Ophthalmology, Metabolic disorders Pulmonology, Autoimmune disorders, Allergies, Gynecology and more.

GET 10% OFF your first order!

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Oncology CNS/Neurology Dermatology Gastroenterology Nephrology and Urology Sarcoma Colorectal cancer Prostate Cancer Breast cancer Chronic obstructive pulmonary disease (COPD) Lung Cancer Cystic fibrosis Ovarian Cancer Gastric Cancer HIV Polycystic Kidney Disease Pancreatic cancer Liver cancer Bladder cancer Glaucoma Non-small cell lung cancer (NSCLC) Small-cell lung cancer (SCLC) Neuroendocrine Cancer Brain cancer Esophageal cancer Biofluids Show 26 more tags Show less

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Fixed Human Tissue

Starting at $95.00 per unit

All Formalin-Fixed, Paraffin-Embedded (FFPE) tissue specimens are collected after strict IRB approval by certified medical pathologists.
Tissues are fixed in 10% Neutral-Buffered Formalin (NBF) within 0 to 60 minutes of surgery excision.
Tissues are fixed for 18 – 24 hours at room temperature, then embedded in IHC-grade... Show more »

All Formalin-Fixed, Paraffin-Embedded (FFPE) tissue specimens are collected after strict IRB approval by certified medical pathologists.
Tissues are fixed in 10% Neutral-Buffered Formalin (NBF) within 0 to 60 minutes of surgery excision.
Tissues are fixed for 18 – 24 hours at room temperature, then embedded in IHC-grade paraffin.
The average sample size is 1 x 1 x 0.3cm, but depending on the nature of the disease or tissue can vary in size and thickness. The fixation agent and embedding media can be customized upon request for all prospective collections! FFPE tissue cassettes are stored at air-conditioned room temperature. The standard-sized FFPE sample can yield at least 100 x 4-5µm cuts.
For specific requests and project parameters, please get in touch with us.
We can produce slides for your project in quantities requested by you. Our standard shipment unit for slides is a dozen (12).

GET 10% OFF your first order!

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Human Oncology CNS/Neurology Fibrotic Disease Dermatology Gastroenterology Nephrology and Urology Metabolism and Endocrinology Endometrial diseases Sarcoma Colorectal cancer Prostate Cancer Breast cancer Chronic obstructive pulmonary disease (COPD) Hepatitis B Hepatitis C Lung Cancer Cystic fibrosis Ovarian Cancer Multiple sclerosis (MS) HIV Polycystic Kidney Disease Thyroid disease Pancreatic cancer Liver cancer Liver Disease Bladder cancer Glaucoma Non-small cell lung cancer (NSCLC) Small-cell lung cancer (SCLC) Neuroendocrine Cancer Esophageal cancer FFPE tissue Frozen Tissue Fresh Tissue Show 35 more tags Show less

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Preclinical Study Design

Price on request
Request a quote for more information about this service.
Rat Rodents Humanized Rat Toxicology

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In vivo Toxicity Testing

Price on request
Request a quote for more information about this service.

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Plasma & Serum Separation

Starting at $3.00 per sample

BCRS offers many Human Biological products for research and clinical purposes. We supply Human Whole Blood, Serum and Plasma. The samples contain blood products from healthy donors and from patients with oncological, autoimmune, infections diseases, diabetes or other diagnoses if needed. We have a variety of samples containing... Show more »

BCRS offers many Human Biological products for research and clinical purposes. We supply Human Whole Blood, Serum and Plasma. The samples contain blood products from healthy donors and from patients with oncological, autoimmune, infections diseases, diabetes or other diagnoses if needed. We have a variety of samples containing infected with HAV, HBV, HBsAg, HCV, HIV1 and HIV2 blood with partial or complete clinical and demographic data.
Our team could offer you specific clinical research samples so please give us a chance to find out what your particular needs are.

All human blood products offered by us are collected at clinical and commercial sites from our network within South East Europe.
Each unit from healthy volunteer is tested and found negative for: HBsAg, HCV, HIV-1, HIV-2, HIV-1Ag or HIV 1-NAT, ALT, and syphilis in accordance with the international GLP standards.

GET 10% OFF your first order!

Show less
Oncology Cardiovascular Gastroenterology Infectious Disease Nephrology and Urology Metabolism and Endocrinology Rheumatoid Arthritis Benign Prostatic Hyperplasia (BPH) Colorectal cancer Spinal cord injury Prostate Cancer Hepatitis B Hepatitis C Staphylococcus aureus infection HIV Polycystic Kidney Disease Rhinovirus infection Bladder cancer Non-Viral Liver Disease Esophageal cancer Urinary tract infection Show 21 more tags Show less

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Human Biofluids

Starting at $5.00 per sample

BCRS provides biofluids collected from healthy volunteers and diseased donors.
• We can also provide biofluids with matching Frozen or FFPE Tissues prospectively.
• Multiple types of biofluids can also be collected from a single donor.

Urine
Stool/Feces
Ascites Fluid
Saliva
Sputum
Synovial Fluid
Cerebrospinal Fluid (CSF)

GET 10% OFF your first order!

BCRS provides biofluids collected from healthy volunteers and diseased donors.
• We can also provide biofluids with matching Frozen or FFPE Tissues prospectively.
• Multiple types of biofluids can also be collected from a single donor.

Urine
Stool/Feces
Ascites Fluid
Saliva
Sputum
Synovial Fluid
Cerebrospinal Fluid (CSF)

GET 10% OFF your first order!

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Melanoma Sarcoma Cirrhosis Benign Prostatic Hyperplasia (BPH) Colorectal cancer Prostate Cancer Breast cancer Hepatitis B Hepatitis C Candida albicans infection Staphylococcus aureus infection Streptococcus pneumoniae infection Non-Alcoholic Steatohepatitis (NASH) Lung Cancer Ovarian Cancer Gastric Cancer Rhinovirus infection Pancreatic cancer Liver cancer Bladder cancer Renal Cancer Show 21 more tags Show less

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Frozen Human Tissue

Price on request

Snap-frozen in liquid nitrogen fresh human tissue, stored on -190C. Specimens can vary between 0.5 to 1.5 g. Prospective collection only!

GET 10% OFF your first order!

Snap-frozen in liquid nitrogen fresh human tissue, stored on -190C. Specimens can vary between 0.5 to 1.5 g. Prospective collection only!

GET 10% OFF your first order!

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Paraffin Embedding

Price on request
Request a quote for more information about this service.

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Paraffin Sectioning

Price on request
Request a quote for more information about this service.

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Clinical Trial Monitoring

Price on request
  • direct, on-site monitoring
  • risk based monitoring (target source data verification)
  • end-point monitoring and support to data collection
  • re-monitoring of data prior to audits and inspections
  • direct, on-site monitoring
  • risk based monitoring (target source data verification)
  • end-point monitoring and support to data collection
  • re-monitoring of data prior to audits and inspections
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Clinical Trial Management

Price on request
  • Monitoring & Timelines
  • Risk management
  • Monitoring & Timelines
  • Risk management
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Medical Affairs

Starting at $900.00 per study
  • Feasibility studies
  • Medical monitoring
  • Safety management
  • Feasibility studies
  • Medical monitoring
  • Safety management
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Data Management

Price on request
  • electronic case report form (eCRF) design, database design and study setup
  • reconciliation of external data
  • reports and listings design and setup
  • data validation and query resolution
  • project management of data and technical services
  • investigator and other users training
  • project performance analyses to support Risk Based Monitoring
  • electronic case report form (eCRF) design, database design and study setup
  • reconciliation of external data
  • reports and listings design and setup
  • data validation and query resolution
  • project management of data and technical services
  • investigator and other users training
  • project performance analyses to support Risk Based Monitoring
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Regulatory Affairs Services

Price on request
  • CTA submissions for local and global trials (phase I-IV) of pharmaceuticals, biological s and bio-similar compounds
  • submissions for medical device trials
  • submissions for non–intervention studies, food supplement studies
  • development of the CTA file/local clinical trial application forms
  • development of drug labels... Show more »
  • CTA submissions for local and global trials (phase I-IV) of pharmaceuticals, biological s and bio-similar compounds
  • submissions for medical device trials
  • submissions for non–intervention studies, food supplement studies
  • development of the CTA file/local clinical trial application forms
  • development of drug labels and/or their adjustment to suit local specificity
  • regulatory maintenance (submission of amendments and all relevant notifications)
  • acting as a direct applicant and point of contact for local authorities
  • acting as a legal representative
  • obtaining import/export approvals for investigational products, ancillary supplies and biological samples
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Quality Assurance

Price on request
  • investigational site audits
  • GCP compliance visits
  • audits of Trial Master Files
  • internal ISO audits
  • training programs
  • effectiveness programs
  • investigational site audits
  • GCP compliance visits
  • audits of Trial Master Files
  • internal ISO audits
  • training programs
  • effectiveness programs
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Clinical Research

Price on request

Trial Types:

•Healthy Volunteers
•Pharmacokinetics/Pharmacodynamics
•Bioavailability/Bioequivalence
•Drug-drug Interactions
•Dose ranging, multiple ascending dose (MAD)
•Phase II–IV clinical trials
•Non-interventional studies
•Clinical trials of medical devices
•Dietary supplements studies
•Food Effect studies
•Patient population Trials

Trial Types:

•Healthy Volunteers
•Pharmacokinetics/Pharmacodynamics
•Bioavailability/Bioequivalence
•Drug-drug Interactions
•Dose ranging, multiple ascending dose (MAD)
•Phase II–IV clinical trials
•Non-interventional studies
•Clinical trials of medical devices
•Dietary supplements studies
•Food Effect studies
•Patient population Trials

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Clinical Trials, Consulting, and Management

Starting at €250.00 per hour

Clinical Trials, Consulting, and Management Services

Clinical Trials, Consulting, and Management Services

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Human Biospecimens

Price on request

Variety of Human Tissue specimens, whole blood, Plasma and Serum.
BCRS can provide you with tailor made solution based on your immediate research needs.
With our vast site network, we are well positioned to design custom specimen collections for a huge variety of clinical indications and diagnosis. Our pathology team, and other... Show more »

Variety of Human Tissue specimens, whole blood, Plasma and Serum.
BCRS can provide you with tailor made solution based on your immediate research needs.
With our vast site network, we are well positioned to design custom specimen collections for a huge variety of clinical indications and diagnosis. Our pathology team, and other laboratory professionals can help in design and effective collection of the materials you need.
We can provide tissue specimens collected at sites in South East Europe and Central Europe.
We have access to more than 80 university and municipal hospitals that would help your research needs.

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Biospecimens

Price on request

Variety of Human Tissue specimens, whole blood, Plasma and Serum.
BCRS can provide you with tailor made solution based on your immediate research needs.
With our vast site network, we are well positioned to design custom specimen collections for a huge variety of clinical indications and diagnosis. Our pathology team, and... Show more »

Variety of Human Tissue specimens, whole blood, Plasma and Serum.
BCRS can provide you with tailor made solution based on your immediate research needs.
With our vast site network, we are well positioned to design custom specimen collections for a huge variety of clinical indications and diagnosis. Our pathology team, and other laboratory professionals can help in design and effective collection of the materials you need.
We can provide tissue specimens collected at sites in South East Europe and Central Europe.
We have access to more than 80 university and municipal hospitals that would help your research needs.

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FFPE tissue Serum Blood Frozen Tissue Fresh Tissue Tumor tissue Plasma Show 7 more tags Show less

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Drug Development

Price on request

BCRS is CRO and provider of variety of services for the drug development industry. We are privately held Bulgarian entity, incorporated in Sofia, Bulgaria (South East Europe) in 2012 with headquarter in Sofia and office in Belgrade, Republic of Serbia. Our satellite partnering office structures located in Budapest, Prague,... Show more »

BCRS is CRO and provider of variety of services for the drug development industry. We are privately held Bulgarian entity, incorporated in Sofia, Bulgaria (South East Europe) in 2012 with headquarter in Sofia and office in Belgrade, Republic of Serbia. Our satellite partnering office structures located in Budapest, Prague, Ljubljana, Skopje and Moscow are supporting our efforts to reach as big as possible diversity of markets, patient populations and indications in respect of fast recruitment of subjects for your trial smooth regulatory process and large volume of bio-specimens as Fresh Tissues, Snap-Freeze tissues and bio-fluids.

Our team of 15 excellent CRAs, Pathologists, Cell-Biologists Clinical Trials assistants is small, but very much experienced. We have participated in successful conduct of more than 45 clinical trials in phases from I to IV during the last 15 years.
During the last 3 years we have collected considerable number of bio-specimens in our repository. The prevailing number of samples are FFPE (Formalin-Fixed-Paraffin-Embedded) cassettes. Currently we're covering more than 37 oncology diseases but we're actively collecting samples for our customers and to enrich our . All samples are classified based on indications, diagnosis, clinical data and demographics.

Understandably all our samples are collected from the big network that we established during the last 3 years in more than 8 EU and non-EU countries. The specimens are collected in 80 academic and clinical institutions according to the local regulatory requirements.

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Clinical Trial Site Selection

Starting at $220.00 per unit
  • collection and review of site-essential documents
  • preparation of site activation packages and direct management of site activation
  • site contracting (country coordinating investigators, primary investigators and sub-investigators, institutions, lend agreements)
  • development of project-specific contract templates
  • collection and review of site-essential documents
  • preparation of site activation packages and direct management of site activation
  • site contracting (country coordinating investigators, primary investigators and sub-investigators, institutions, lend agreements)
  • development of project-specific contract templates
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Tissue Embedding

Price on request

Tissue Embedding Services

Tissue Embedding Services

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Tissue Processing

Price on request

Tissue Processing Services

Tissue Processing Services

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Tissue Sectioning

Starting at $7.50 per slide

Tissue Sectioning Services are available for all 78 malignancies from our FFPE store. Healthy tissues can be provided upon request. The shipment pack is a dozen (12) slides.

Tissue Sectioning Services are available for all 78 malignancies from our FFPE store. Healthy tissues can be provided upon request. The shipment pack is a dozen (12) slides.

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Clinical Ancillary and Sample Services

Price on request

Clinical Sample Services

Clinical Sample Services

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Blood Banking and Transfusion Medicine

Price on request

Blood Banking and Transfusion Medicine Services

Blood Banking and Transfusion Medicine Services

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Clinical Hematology

Price on request

Clinical Hematology Services

Clinical Hematology Services

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Clinical Laboratory Services

Price on request

Clinical Laboratory Services

Clinical Laboratory Services

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Toxicology

Price on request

Toxicology Services

Toxicology Services

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Pharmacology & Toxicology

Price on request

Pharmacology & Toxicology Services

Pharmacology & Toxicology Services

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Drug Discovery & Development

Price on request

Drug Discovery & Development Services

Drug Discovery & Development Services

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Human Tissue Procurement

Price on request
Request a quote for more information about this service.

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Phase IV Clinical Trials

Price on request
Request a quote for more information about this service.

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Phase III Clinical Trials

Price on request
Request a quote for more information about this service.

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Phase II Clinical Trials

Price on request
Request a quote for more information about this service.

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Phase I Clinical Trials

Price on request
Request a quote for more information about this service.

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Animal Model Housing and Maintenance

Price on request
Request a quote for more information about this service.

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Medical Imaging Services

Price on request
Request a quote for more information about this service.

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Animal Models and Studies

Price on request

Animal Models and Studies Services

Animal Models and Studies Services

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Animal Models of Disease

Price on request
Request a quote for more information about this service.

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Simeon Simeonov

Chief of Operations

BCRS - Balkan Clinical and Regulatory Services Ltd. has not received any reviews.

BCRS - Balkan Clinical and Regulatory Services Ltd. has not received any endorsements.