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Pharma Services Category of Greenleaf Health Inc

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Clinical Development / Phase IIb-IV

Compliance, Regulatory & Consulting

Post Marketing

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Greenleaf Health Inc

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UNITED STATES

Premarket Preparation

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- Service Details

Greenleaf Health Inc. offers various services such as: Combination product designations; Requests for device classification (513(g)); Presubmission strategy; Identification of predicate devices; Determination of and compliance with performance data and labeling requirements; etc.

- Directory Listing

Pharma Service: Clinical Trials

Category: Clinical Development / Phase IIb-IV

Sub Category: Phase IV

Premarket Submissions

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- Service Details

Greenleaf Health Inc. offers various services such as: 510(k) premarket notifications; Premarket approval applications (PMAs); Requests for de novo review of automatic Class III classification; Humanitarian use designation (HUD) / humanitarian device exemption (HDE) applications; etc.

- Directory Listing

Pharma Service: Clinical Trials

Category: Clinical Development / Phase IIb-IV

Sub Category: Phase IV

Marketing & Promotional Practices

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- Service Details

Greenleaf Health Inc. offers various services such as: Strategic guidance on labeling requirements; Promotional materials; Direct-to-consumer advertising review processnRemediation of untitled and warning letters; Use of social media.

- Directory Listing

Pharma Service: Clinical Trials

Category: Clinical Development / Phase IIb-IV

Sub Category: Phase IV

Advisory Services

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- Service Details

Greenleaf’s advisory services include research and analysis of the following potential sources of risk: Marketing authorization; Manufacturing and quality; Promotion; Distribution and supply chain; Pipeline analysis; Compliance status; Labeling; Product safety

- Directory Listing

Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Consulting Services

Product Lifecycle Management

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- Service Details

Greenleaf Health Inc. offers various services such as: Strategic guidance on FDA’s regulatory process; All aspects of product development; Premarket review; Postmarket safety requirements; Analysis of the market to identify potential competition.

- Directory Listing

Pharma Service: Clinical Trials

Category: Post Marketing

Sub Category: Pharmacovigilance / Product Lifecycle Management

Regulatory Policy Guidance

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- Service Details

Greenleaf Health Inc. offers various services such as: Analysis of FDA policies and processes; User fee requirements; Advisory committee analysis; Implementation of new FDA legislation, regulations, guidance documents and FDA standard operating procedures.

- Directory Listing

Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Regulatory Affairs

Analysis & Expert Consultation

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- Service Details

Greenleaf provides regulatory analysis for strengthening: Corporate quality systems; Corporate training programs; Corporate compliance strategies; Inspection readiness; Corporate quality and compliance organization

- Directory Listing

Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Consulting Services

Regulatory Guidance

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- Service Details

Greenleaf provides corporate insight on: FDA inspection, compliance and enforcement processes; FDA organization and structure as they relate to compliance functions and decisions; Impact of compliance-related legislation, regulations and guidance; FDA trends and priorities

- Directory Listing

Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Regulatory Affairs

Corporate Training & Development

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- Service Details

Greenleaf provides training and development for: Issuing technical reports, determining policies and procedures, and revising company SoPs; Preparing for FDA meetings and facilitating effective interactions with FDA; etc.

- Directory Listing

Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Training

FDA Communications

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- Service Details

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.

- Directory Listing

Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Quality & Compliance

Pharma Services Category of Greenleaf Health Inc

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