Existing Partners Part 1

thinqbetter UG

thinqbetter specializes in medical device and IVD product registrations in Europe and the USA. For this purpose, they offer consulting and services throughout the entire product life cycle. Through their internal expertise and cooperation partners, the most complex projects can be realized.
Their satisfied clientele includes companies with double-digit billion euro turnovers, as well as start-ups with 1-2 employees.

Key information
Type: Regulatory consultancy in the medical device industry
Country: Germany
Core activities:
  • Creation of quality management systems (ISO 13485)
  • Creation of clinical evaluation reports (EU 2017/745)
  • Creation of performance evaluation reports (EU 2017/746)
  • Creation of biological evaluation reports (ISO 10993-1)
  • Creation of technical documentations and product dossiers (EU 2017/745, EU 2017/746, PMN 510(k))
Website: www.thinqbetter.com

Holochem is a customer-oriented CRO offering chemistry manufacturing and control services for the development of fine chemicals and drug substances for the pharmaceutical chemistry, animal health, cosmetics and agro-sciences industries. Holochem provides R&D services for the development of small and complex molecules, key intermediates, and APIs, highly potent APIs & ADC linkers, impurities, metabolites and reference standards. We produce non-GMP pre-clinical batches from milligram to kilo-scale for early-phase formulation and toxicological use.

Key information
Type: Small CRO
Country: France
Core activities:
  • Impurity identification and synthesis
  • Reference standards characterization and synthesis
  • Custom and toll synthesis
  • Chemical development
  • Process development
Website: https://www.holochem.com
Invisio Clinical Studies Consulting UG

Invisio is your partner for national and international clinical phase 1 to phase 4 studies at medical practices and clinics without their own research department.

As an interface between sponsors and CROs, as well as physicians and patients, we have been enabling national and international clinical studies for about ten years. For this purpose, we work together with more than 120 trained Flying Study Nurses and CRAs. They support physicians 365 days a year at all times to implement on-site clinical study projects in compliance with international quality standards.

We specialize in providing project management for clinical multicenter studies and, at the same time, implementing study projects at several trial centers throughout Europe. We are available without restrictions to our customers and all other persons involved in a study as a contact partner.

Key information
Type: Clinical Studies Consulting
Country: Germany
Core activities:
  • Flying Study Nurses
  • Project management for Multicenter Studies
  • Optimized Patient Recruitment
  • Standard Operating Procedure – SOP
  • Study Portfolio Optimization
Website: https://invisio.info/en/
JBD HealthCare (Jhonatan Bringas Medical Technology)

JBD HealthCare is a Medical Technology strategy consultancy firm that focuses on development, product management, implementation and go-to-market of different Digital Health solutions. Our core of expertise is in the usage of data and Digital Biomarkers applied to clinical medicine or Research.

Key information
Type: Decentralized Digital Trial and Digital Health Strategy consultancy firm
Country: The Netherlands
Core activities:
  • Strategy development
  • Medical Affairs
  • Technology Development
  • Medical Communications
  • Go-to-market strategies
Website: https://jbdhealth.care/
Pharmapoint S. A.

PHARMAPOINT S. A. is a part of Pelion Healthcare Group as a part of the wholesale business line provides clinical trials logistics services including: market research; documentation gathering and analysis; product sourcing and acquisition; product storage including ambient and cold chain stock in accordance with GDP; logistic and distribution support; product kitting, labelling and repacking.

The range of services is constantly enlargened and adjusted to changing market conditions. We are open to new forms of cooperation and continually analyze trends on the pharmaceutical market to meet the expectations of our business partners.

Key information
Type: Wholesaler
Country: Poland
Core activities:
  • Product sourcing and acquisition;
  • Product storage including ambient and cold chain stock in accordance with GDP;
  • Logistic and distribution support
Website: www.pharmapoint.pl
Arensia Exploratory Medicine

ARENSIA has its own network of nine state of the art exploratory medicine units with full Phase I / II / PROOF OF CONCEPT patient capabilities. These modern units are located within dedicated areas in prestigious University Hospitals in Romania, Republic of Moldova, Georgia, and Ukraine.

ARENSIA has been building deep relationships with each of the hospitals where our units reside. This has allowed ARENSIA to achieve industry leading recruitment rates across a number of therapeutic areas, whilst still maintaining the highest resulting data quality.

Key information
Type: Clinical Research Company
Country: Germany
Core activities:
  • Fast patients recruitment in Phase I / II
  • Proof of concept clinical trials
Website: https://www.arensia-em.com/
Quinta – Analytica s.r.o.

Quinta-Analytica is well recognized one-stop-shop company offering full package of the services in Phase 1 Clinical testing, Bioanalytical testing, Pharmaceutical analyses including analytical development and stability testing.

Quinta-Analytica was inspected by FDA more than 10 times already with no findings. Besides of above mentioned, we offer also expertise in batch release, analytics of inhalers, peptides and proteins (large molecule analyses generally including biosimilars) as well as consultancy in Regulatory and Clinical Strategy. We are located in Prague, Czech Republic.

Quinta-Analytica operates in full compliance with GCP/GLP/GMP and also FDA standards. Due to joint-venture laboratory located in Russia we can support our business partners also in terms of their needs of pre-clinical and clinical studies on Russian market.

Key information
Type: Medium Phase 1 CRO with Bioanalytical lab onsite
Country: Czech Republic
Core activities:
  • BE/BA/PK clinical studies
  • Bioanalytical testing
  • Analytical method development
  • Stability testing
  • IMP batch release
Website: https://www.quinta.cz/en-eu/home
Rephine Ltd.

Rephine is a global pharmaceutical consultancy founded in 1998 that focuses on GCP and GMP compliance, as well as regulatory matters. Rephine has an extensive library of over 190 GMP audit reports that covers 7,390 individual products which makes Rephine the largest provider of third-party GMP audit reports in Europe.

Rephine GXP consultants are a global group of highly professional and experienced personnel who have worked with multinational pharmaceutical organisations and CROs able to provide outstanding GCP and GMP service at very competitive price schemes. Rephine provides first class pharmaceutical manufacturing consultancy, QP Services and Due Diligence services and a full range of GCP services.

Key information
Type: Pharmaceutical consultancy
Country: the United Kingdom
Operational in 56 countries, with branch associates in the USA, Asia and Europe (France, Spain, Italy and Germany)
Core activities:
  • GMP, GCP and GLP services, such as audits, mock inspections, training, and gap analysis
  • GMP, GCP and GLP services, such as audits, mock inspections, training, and gap analysis
Website: www.rephine.com
Pharma Professionals

At Pharma Professionals we have developed capabilities to support clinical trials with home-care services that help enhance the quality of patients’ lives while maximizing recruitment and retention for our clients.
Our GCP-trained personnel visit patients at their homes or work and are responsible for activities including sample collection, vital signs documentation, study-drug administration, monitoring changes in patient health, and visit documentation.

We also deliver a wide range of staffing solutions to Pharmaceutical, Biotechnology, and Clinical Research Organisations as well as Medical Device and Diagnostics companies across Europe.
We recruit professionals who work with human as well as animal-health products, including pharmaceuticals, vaccines and biologics in addition to consumer health products.

We serve both innovative and generic clients. We work with both corporate organizations listed among top 50 global pharmaceutical and biotechnology companies as well as with midsized and small life-science companies.

Key information
Type: Clinical Trial Support and Recruitment Company
Country: Poland
Core activities:
  • Clinical trial support
  • Home care visits
  • Personnel outsourcing
  • Executive search
  • Recruitment
Website: https://www.pharmaprofessionals.eu/

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