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JEMMDX
  • Home
  • What We Do
  • Who We Are
  • Core Services
  • Insights

Bespoke capabilities across the product lifecycle

Developing and delivering youR strategy

Our expertise includes:


  • Product strategy and claims development
  • Clinical and regulatory pathway development 
  • Clinical support- Specimen access, Protocols, Clinical studies, reports (Regulatory, Post launch/RWE, Usability)
  • Quality management system (ISO 13485) 
  • IVDR/UKCA gap analysis and remediation
  • Regulatory submissions (UKCA, EU IVDR, FDA, WHO, PMDA etc.)
  • Stakeholder engagement/ advocacy
  • Medical communications- journal papers, white papers, conference symposia

Our services

Diagnostics and device experience

Infectious Diseases:

SARS CoV-2(Ag, Ab, PCR), Flu A/B, RSV, Strep A, Adenovirus, Strep pneumo, Legionella, Chlamydia, HIV, HBV, HCV, Pneumocystis, Leishmania, Malaria, Dengue, Lyme, Giardia, Tuberculosis (TB), C Diff, H pylori, UTI, HIV, Syphilis, Neisseria Gonorrhea, T vaginalis, Candida

Womens Health:

HCG (Prof & OTC, qualitative, semi-quant and quantitative), Conception Indicator, PLGF/sFLT (pre-eclampsia), PROM, Preterm, Strep B, AMH, LH, FSH, estradiol (E3G), progesterone (PdG), Testosterone (TG), TSH, Menstrual Migraine prediction, Osteoporosis (bone markers), Menopause/Perimenopause Onset, Fertility Monitoring (LH/E3G/PdG/AMH), Bacterial Vaginosis

Cardiovascular:

hs Troponin, NTproBNP, BNP, Lipid profile, CK-MB, Myoglobin

Diabetes:

HbA1c, Glucose, Ketones, C-Peptide

Coagulation / Haematology:

PT-INR, D-Dimer

Antimicrobial Resistance:

CRP, PCT, novel AMR technologies 

Oncology:

BTA, NMP-22, FOBT, novel biomarker evaluation

Renal:

ACR, Cystatin, NGAL

Sexual Health:

Bacterial Vaginosis, Candida, T vaginalis, Syphilis, Gonorrhea, Chlamydia, HIV 

App Software Regulatory Development Support and User/Clinical Trialing

experience

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