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.
Starodub BV offers comprehensive support for (bio)pharmaceuticals and medical devices throughout their lifecycle. For (bio)pharmaceuticals, we efficiently guide the development and registration of medicinal products, including small molecules, biologics, biotechnology-derived products, ATMP and vaccines. With a strategic approach focusing on a helicopter view, we address potential opportunities, risks, and solutions. Our services cover various applications, regulatory frameworks, and interactions with global health authorities, promoting quick market access and cost-effectiveness.
In the medical device sector, Starodub BV facilitates the development and registration of class I to class III devices, including software, in vitro diagnostic products, and drug-device combination products. We assist in establishing ISO 13485 compliant quality management systems, ensuring efficiency in time and cost. The company’s four-pillar approach emphasizes maintaining a strategic overview, identifying opportunities, communicating risks, and finding optimal solutions. Services include qualification, classification, design, development, marketing, clinical/performance evaluation, risk management, post-marketing activities, and regulatory intelligence. Starodub BV also provides tailored training programs and regulatory operations support.
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.
Medezin provides a wide range of services to support all stages of sales development on the pharmaceutical market. Our support involves import of medicinal products and their certification, storage in controlled conditions, distribution and reaching out to key institutions on the health care market. A part of our services is dedicated to clinical trials, in phase I-III. The scope of services include import (parallel, interventional and destination) of medicinal products with the necessary documentation, i.e. COA, BRC, COC. Also we are sourcing clinical ancillaries and samples for research. In our manufacturing facility we can do secondary packaging, labelling of primary packaging, randomization and blinding, serialization. The scope of our services is in accordance with GMP, GDP and GCP, we have qualified persons in our team. Manufacturer’s warehouse is able to storage in temperature controlled conditions over 800 pallets places. Additionally, we offer distribution services and support with returns and disposal.
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.
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.
Rephine is a firm of deeply experienced GxP consultants, auditors and practitioners. The company proactively helps pharmaceutical, biotech and medical device companies with all aspects of their manufacturing and supply chain quality assurance and associated business process optimisation.
Widely acknowledged to be the gold standard in its field, Rephine has been providing these specialist quality assurance services for more than 25 years. Rephine is a founding member of 3PARL®, a consortium that aims to set a new benchmark for consistent, reliable, high-quality supply chain Good Manufacturing Practice (GMP) audit services and library reports.
We are a provider of home care services in clinical trials in Poland and CEE region.
MedSurgPI is a leader in product development for drugs, biologics, devices, and diagnostics, offering a suite of medical expertise services, including clinical strategy, FDA interactions, and protocol development. We provide fractional medical services, CRO management, and comprehensive safety evaluations through DSMB, CSR, and CEC. Our medical affairs team excels in communications, regulatory review, KOL management, and CME, ensuring excellence across all phases of development and compliance.
INNOPROOF GmbH is accredited per ISO 17025:2018 standards and offers pre-clinical testing of mammary implants, total joint replacements (hip, shoulder, knee), osteosyntheses, spinal devices, dental implants as well as testing of bone cements and coatings.
INNOPROOF is specialized in physical-mechanical testing such as fatigue strength, fracture toughness or static rupture of medical devices. We also test surgical instruments from the different branches. A newly introduced service is testing of packaging, for example compression testing and dye penetration testing. If there are no standardized tests for a special product, we will develop the appropriate methodology to already acquire a high level of safety in the preclinical phase. The founders of INNOPROOF are two opinion leaders in the biomechanics community with strong scientific background. INNOPROOF is located in Rostock, Germany, at the baltic coast, about 2 hours from Hamburg and 2 hours from Berlin.
