Factory CRO

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CE MARKING

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We are well acquainted with CE-marking studies and can assure that your study can be designed and controlled to meet the demands of Notified Bodies.

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Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Quality & Compliance

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Lovelace Scientific Resources

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QUALITY ASSURANCE

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When contracting with LSR Trials, you can be assured that we will meet all deadlines and the data will be immaculate to ensure a successful trial.

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Pharma Service: Clinical Trials

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Icon Plc

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QUALITY & REGULATORY SUPPORT

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Mapi provides customers with assistance on quality and compliance matters, including pharmaceutical quality assurance, medical device quality systems, and clinical compliance (GCP).

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Sub Category: Quality & Compliance

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TFS International AB

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PREPARATION & SUBMISSION OF CTA/ITA, IND, PMA / 510 (K)

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The TFS Global Clinical Development Team provides strategic advice on clinical development. TFS’ team of specialists in clinical development, early phase development, regulatory affairs, and medical experts in a broad range of therapeutic indications support our customers in their clinical

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Factory CRO

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INTERNATIONAL CLINICAL TRIAL RESCUE

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We are proud to offer our early-detection program designed to help medical device companies correct poorly designed clinical trials, effectively saving the study from ultimately being rejected by FDA or European regulators.

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Pharma Service: Clinical Trials

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KAI Research

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QUALITY ASSURANCE OF TRIALS

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Our long experience in validating clinical studies has allowed us to strengthen internal procedures to maximize accountability, systematic feedback, and quality control in all aspects of studies and data handling.

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Pharma Service: Clinical Trials

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Factory CRO

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FDA REGULATORY STRATEGY

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Factory’s team has a broad and in depth knowledge on FDA requirements and procedures and can help you design a regulatory strategy specific for your device.

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Greenleaf Health Inc

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FDA COMMUNICATIONS

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Greenleaf provides evaluation and response recommendations for: Facility and supply chain audit reports; cGMP deficiency letters; Establishment inspection reports (EIRs)nFDA Form 483s; Warning letters; Untitled letters; Other compliance- and enforcement-related actions.

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Chiltern International Ltd

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PRODUCT LABELING TESTING

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Chiltern’s Strategic Regulatory team is your end-to-end solution for navigating regulatory processes throughout your product’s life cycle. Our team uses a collaborative approach to generate a personalized strategy that aligns with your business goals and gives you the best chance of regulatory

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Factory CRO

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EUROPEAN REGULATORY STRATEGY

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We would be happy to provide a free consultation about your European regulatory strategy, without any future obligation. We can assist with Notified Body selection and negotiations.

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Pharma Service: Clinical Trials

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PPD

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CLINICAL QUALITY & COMPLIANCE SERVICES

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PPD's clinical quality assurance (CQA) services help our clients ensure the integrity of their clinical trials. We advise clients on how to verify the integrity of scientific data and ensure adherence to protocols and international regulatory guidelines. We also help clients protect research

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TFS International AB

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GLOBAL QA & COMPLIANCE

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At TFS we strive to ensure costs are kept within the budget using our in-depth knowledge of international and local regulatory requirements and our network of global investigators to ensure that the trial objectives will be met on time.

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TFS International AB

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QUALITY ASSURANCE

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TFS Quality Assurance (TFSQA), an independent group within TFS, is responsible for ensuring the quality of the work provided by TFS, and that all work is conducted in compliance with applicable GxP guidelines, relevant regulatory requirements and applicable Standard Operating Procedures (SOPs).

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