EU/UK Qualified Person (QP) Services and MIA license
Product Description
ProPharma Group
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NL -
2022On CPHI since
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5Certificates
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1000 - 4999Employees
Company types
Primary activities
Categories
Specifications
ProPharma Group
-
NL
-
2022On CPHI since
-
5Certificates
-
1000 - 4999Employees
Company types
Primary activities
More Products from ProPharma Group (7)
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Product Clinical Research Solutions
We design and execute clinical trials so new therapies get to market in the quickest and safest way possible. Full-Service Solution: We manage and execute full-service clinical trials across major therapeutic areas within medical device, diagnostics, drug, and biologic. Functional Service Provisi... -
Product Computer System Validation (CSV) Solutions
ProPharma's validation professionals leverage the latest risk-based Computer System Validation (CSV) and Computer Software Assurance (CSA) techniques to ensure that our clients' systems are ready for inspections from the FDA, EMA, MHRA, and other regulatory agencies. Our consultants have extensive experien... -
Product GxP Audits and Inspection Readiness
Our auditors have real world experience supporting regulatory inspections and preparing companies for pre-approval inspections. Our team of specialists includes former regulatory agency inspectors and qualified auditors who are proficient in conducting mock inspections, internal audits, vendor and s... -
Product Hi-End Resource On Demand Solutions
Project resource management includes forecasting the need to hire and/or outsource some tasks. When projects are high-value and require strategic decisions, in-house resources may be insufficient. Similarly, administrative action items are better left to contract workers so as to not overburden your staff.... -
Product Accelerating Your Product Through Development
ProPharma’s Drug Development Team is a multidisciplinary team of scientists, engineers, nonclinical, clinical, and quality experts with the experience to guide drug through development.
Our unique combination of expertise in US and EU Regulatory Affairs, CMC, and GMP allows us to connect... -
Product Quality & Compliance Solutions
From early-stage development through commercial support, our experts provide critical GxP-based consulting services. We partner with clients to successfully execute projects throughout the product lifecycle to maintain quality & compliance with applicable regulations and industry standards. qq... -
Product Regulatory Sciences
From early-stage development to post-approval, we partner with pharmaceutical, biotechnology, and medical device clients to overcome regulatory hurdles. Using science as the driver for success, we help our clients achieve positive regulatory outcomes with the Food and Drug Administration (FDA), Europea...
ProPharma Group resources (1)
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News Propharma: The World's Largest RCO
RCO Vs CRO: Drug and Device Development Outsourcing 2.0
Traditional CRO push a full-service, "cookie-cutter" agenda, offering little compromise for the small Sponsor; ProPharma’s Research Consulting Organization RCO model leads with strategy to help de-risk programs and create tailored solutions to maximize probability of success.
ProPharma has transformed its organizational structure and solutions to put its clients at the very center. We offer a suite of bespoke consulting solutions across service lines and functional areas of expertise to span the full product life cycle. ProPharma embraces partnerships to reduce delays and drive consistency with dedicated and experienced strategists and program managers for end-to-end oversight.
Frequently Viewed Together
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Product Validation
Our team of experts will prepare necessary protocols incorporating all critical parameters
Process Validation:
PharmEng professionals possess experience in validating pharmaceutical and biopharmaceutical manufacturing processes. Our team of experts will prepare necessary protocols i...
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Product GO!FIVE Digital Validation Solution
Global Verification & Validation is a SaaS solution for Life Science companies that complies with EMA/FDA. FIVE Validation developed a SaaS platform that allows AI and traditional validation studies to proceed 6x faster than a manual (electronic or paper-based) process.
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Product USFDA Compliance & Regulatory
Preparing for a USFDA Inspection and managing the post inspection situation requires a high level of expertise and PharmSol offers a comprehensive solution in that direction.-Compliance Management
-Product Development
-Regulatory Support
-BD Support
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Product Biologic drug substance CDMO services
From pre-clinical development to commercial supply, Patheon by Thermo Fisher Scientific is an industry leader in the development and manufacture of mammalian cell culture drug substances. Patheon offers biotech and pharmaceutical companies the ability to pursue opportunities around the globe with a fully i...
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Product Arabmed CRO
ArabMed CRO is renowned for its expertise in conducting clinical trials across all phases, from Phase I to Phase IV, with a strong track record in drug research. The company also excels in medical device clinical investigations, demonstrating its commitment to advancing medical technologies. With a focus o...
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Product Audits
Due to recent regulatory developments concerning raw materials, suppliers, manufacturing and distribution, auditing has become a task of critical importance for Life Science businesses.PQE Group supports Pharma and MD companies in performing many types of certified audits, from routine monitoring to due di...
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Product Clinical Trial Services
Our experts will accomplish your clinical objectives by leading the way from recruitment strategies, site selection, and clinical logistics, all the way through the regulatory process.
We use our own eClinical suite to be more cost-efficient and keep you connected remotely acros...
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Product Value-added generic development
Avivia offers full product development services to generic drug companies and specialty pharma focused on the development of new improved versions (value-added generics or generic plus) of established drug products.
Although in general the overall aim of value-added generic development projects is focu...
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Product Quality Operations Support
• Management Review • Validation and Qualification • Risk Management • Laboratory Controls • Batch Review • Quality Engineering • Exceptions • Post Market Surveillance
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Product State-of-the-Art Depot Facilities
• Pro-active and flexible system of project management
• Comprehensive reporting system
• Additional labeling
• Returns/recalls
• All temperature-controlled regimes
• Temperature and humidity monitoring system
...
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Product HVAC , DUCTING AND BMS
IN HOUSE TECHNICAL STRENGTH CONCEPTUAL-BASIC-DETAIL DESIGN ERECTION-COMMISSIONING-VALIDATION COMPLIANCE-BMS 21 CFR PART 11
AHU –DH UPTO 35% EFFECTIVE LATENT COOLING HIGH ENERGY PERFORMANCE LOW CAPITAL INVESTMENT
CHILLER COOLI...
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Product Clinical Supply
Recipharm have more than 20 years experience supplying clinical trial material to our clients. Our development facilities cater for a range of clinical trials from preclincal to smaller Phase III trials. We also offer commercial manufacturing for very large clinical batches.
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Product RoSS.pFTU: Controlled Freezing & Thawing Platform
The plate-based freeze-thaw platforms from Single Use Support enable controlled freezing and thawing of drug substances. Transferable recipes enable full scalability and compatibility from the lab to blockbuster production. Thanks to RoSS technology all batch sizes and single-use bags from all establi...
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Product Regulatory Affairs and Pharmacovigilance
UAB Eletis Medica offers wide range of products and services which includes regulatory affairs and pharmacovigilance services. Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse event or other medicinal products related problem....
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Product Custom Protein Synthesis
We provide a Custom Protein Synthesis Service, using a chemical method that synthesises proteins amino acid by amino acid and making modifications on an atomic-scale. We work closely with our partners in designing, customising and optimising the proteins that is synthesized in an automa...
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Product Tramadol HCl
Grünenthal GmbH offers a selected range of products which includes Tramadol HCl, as API, bulk and/ or finished dosage form. Please contact us for more information.
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Product Biocatalyst production
Is the enzyme you are interested in not commercially available and a production needs to be developed? Enzymicals has extensive expertise with scale-up from lab to pilot-scale and technology transfers to industrial manufacturing sites. We can supply your protein by in-house production up to the kg-scale...
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Product Antibody Drug Conjugates (ADC)
hen selecting AbbVie Contract Manufacturing, you are partnering with a leading developer and manufacturer focused on accelerating and mitigating risks to program timelines and on efficiently fast-tracking your program to completion. AbbVie’s mAb and ADC state-of-the-art facility and expert scientific team ...
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Product Small Molecule - Phase 3 or Commercial Support
Taking the molecule to market• Fate & purge studies
• Impurities marker synthesis &qualification
• Design of experiments
• Critical process parameters studies
• Preparation for, and execution ofprocess validation
• Continuing CMC support during &after market launch
• Technolog...
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Product Drug Product Development
Our Vetter Development Services help biopharma customers lay a foundation of scalability, quality, and sustainable value for drug product profiles. We support drug developers in navigating key steps, decisions, and transitions in the product development cycle. This includes primary packaging evaluation, pr...
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Product Clinical API Development
CARBOGEN AMCIS has a DNA in API development, stretching back over 30 years. Our API development teams are selected for their passion for science and experience in the application of phase-appropriate efforts to solve challenging chemistry issues. From taking a promising molecule from our clients' medicinal...
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Product Supply Chain Services
With a dedicated team of experienced supply chain specialists, we go far beyond conventional offerings to provide you with innovative and efficient supply chain solutions. With three strategically placed warehouses in Switzerland and Germany, we are able to store and distribute your products in a ...
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Product Ultra-low Temperature Commercial Solutions
Working collaboratively with our clients, we specialize in providing innovative, tailored solutions supporting advanced therapy (cell and gene) product launches, Just in Time labelling and packaging at ultra low temperatures, QP release and 3PL supply chains.
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Product GMP-Support: Qualification / Validation / Consulting
Quasaar does not see itself as "processing office" of service contracts.
As an outsourcing partner, Quasaar also focuses on problem solving, increasing efficiency and process optimization, including on-site consulting and project management.
Our expertise includes i.a. following topics: ...
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Product Analytical Services
With a team of experienced scientists and a robust toolbox of analytical techniques and equipment, Experic can support the life cycle of your oral solid dose and/or inhalation pharmaceutical products. Our laboratory staff provides comprehensive analytical solutions to support the formulation, development, ...
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Product Healthcare Polymer Solutions
Our wide-ranging product portfolio includes brands by well-known polymer manufacturers. We are therefore able to provide a wide variety of different plastics that have been specially developed for the healthcare sector.
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Product Business Support
The Investment and Development Agency of Latvia (LIAA) is a direct administration institution subordinated to the Minister of Economics of the Republic of Latvia. LIAA supports companies in Latvia trading internationally as well as overseas enterprises seeking business partners in Latvia. LIAA promote...-comp247049.png)
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Product Ampoule Tray floding boxes
IGB Ampoule Trays are entirely madeof cardboardThey are safe, eco-friendly and easyto us
They are made by a state-of-the-artmachine, designed by IGB: unique inItaly and most advanced in Europe.
The trays are ideal for the packagingof pharmaceutical and cosmetic vialsand ampoules
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Product Clinical Manufacturing
.Integrated drug development service (CRO/CDMO) including clinical manufacturing and management.
The range of activities offered by Bluepharma includes:
- Clinical material cGMP manufacturing
- Clinical supply management
- clinical material
- placebo
- ...
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Product Product nursing (distribution & promotion)
"Product Nursing" is the Jakin group solution to full-outsource your pharmaceutical, parapharmaceutical and medical device products in Italy. Product Nursing combines the normal distribution and product logistics activity with the excellence and leadership of Jakin group in multi-channel medical-scien...
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Product Storage And Logistics
Lichtenheldt has a total storage area of 5000 m² for up to 8000 pallets of products and raw materials. The organization of the warehouse and the product flow within our plant is perfectly adjusted to perform a high service level according to the demands of our customers. Through our modular alignment w...
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Product COMPLIANCE
AUDITING: - Support its clients on Vendor Audit; COMMISSIONING:- Manages and performs commissioning activities for new systems, equipments and facilities;
TESTING:- Performs the following testing activities using its own instrumentation saving costs and time on tests planning;
COMP...
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Product Logistics & Distribution
Our logistics and distribution department provides tailor-made and innovative services for your product. Contact us to learn more about our logistics and distribution offers.
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Product Wasdell Storage & Distribution
Our integrated storage, fulfilment and distribution facilities have the capacity to store over 26,000 pallets. We offer ambient, controlled ambient, cold chain and controlled drug (up to schedule 2) storage conditions. Online inventory, ordering and real-time reporting is accessible 24/7 fro...
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Product Passionis
Passionis is a unique product specially for women, which have been related to sexual appetite boost properties, containing Liboost, Maca, Vitamin B6 and Zinc.
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Product ANDA and NDA Technical Support
As part of its commitment to full service support, Avéma Contract Services is pleased to offer our customers support with ANDA and NDA applications, including bio equivalency studies, collecting background data, supervising technology tranfers and reviewing applications to make sure that companies com...
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Product Drug Development Consulting
Our Drug Development Consultants work with you to design and implement successful drug development programs. With industry leading scientific expertise across a range of technical disciplines, we help customers across all stages of development, from candidate selection to commercial launch.
Our cons...
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Product ABC Transfer® Alpha Port
Our range of rapid transfer ports, ABC Transfer’s Alpha Ports, ensure safe sterile and aseptic transfers for isolator systems in pharmaceutical filling lines. Our Alpha ports, rapid transfer port are compatible with other brands and fully comply with the Annex 1 of the European GMP.
...
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Product Auditing
Our pharmaceutical auditing and management services give you a transparent view of your supply chain enabling you to identify and mitigate the intrinsic risk in your operations, supply chains and business processes. Through our shared audit programs, delivered by our global network of specialist audit...
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Product Consulting: ICH Q10
Pharmaceutical companies must be capable of delivering products to the market with the utmost level of quality and safety. At Zamann Pharma Support, we have been aiding large and mid‐sized pharmaceutical companies in solving quality and compliance challenges while ensuring that practicality and qualit...
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Product OC11 Word Platform
The OC 11 Platform is not just another software; it's the next generation of Global GxP and Data Integrity solutions. It's designed to revolutionize how GxP records are generated and to ensure users comply with global GxP and Data Integrity regulatory requirements..
Convert any Word form i...
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Product Quality & Compliance Solutions
From early-stage development through commercial support, our experts provide critical GxP-based consulting services. We partner with clients to successfully execute projects throughout the product lifecycle to maintain quality & compliance with applicable regulations and industry standards. qq...
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Product Good Clinical Practice (GCP) auditing services
Rephine provides a high-quality service in a timely and cost effective manner, from a single advisory activity to full GCP audits, or Quality Management programme and training. Rephine provides tailor-made solutions that meet the unique needs of your organisation.
Rephine’s portfolio of GCP services i...-comp267516.png)
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Product PILOT BATCHES AND REGISTRATION BATCHES CONTRACT MANUFACTURING
TECNALIA, experts in Pharmaceutical Development, Scale-up & Pilot Batches Manufacturing, Clinical Trials and Contract ManufacturingPilot
Batches and Registration Batches /
• Manufacture in compliance with the principles and guidelines of GMP for medicinal products.
• Transfer o...
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Product e-Reg: management of Regulatory Affairs' big data
OP Pharma has been providing all-around services in the Regulatory Affairs field for more than 20 years to small to big pharma Companies in Italy as well as in the European Union.
Do you have lots of products and/or products' data which you cannot organize/archive interna...
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Product Clinical batch production
XEDEV can support clinical batch manufacturing up to Phase IIb in our clean rooms after succesfull development.
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Product Klinea Pharmaceutical Engineering
KLINEA is a company fully committed to providing added value solutions for the life sciences industry, specialized in Engineering Services, Project Management and Quality Scrutineering Tests, with offices in Madrid and Barcelona. Founded by a highly qualified technical team with more than 15 years of e...
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Product Reference Materials Management Services
To support you in bringing even safer medicines to the market, we go far beyond supplying you with the right reference standards. From impurity profiling and working standards outsourcing services, all the way to managing inventory and logistics of your reference standards, we’re fully equipped to provide ...
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Product Analytical Development:
•Development and validation of analytical methods to ensure accurate quantification, purity assessment, and impurity profiling.
•Characterization of raw materials, intermediates, and final APIs using techniques such as HPLC, GC, MS, NMR, and XRPD.
•Stability studies and fo...
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