The FDA Group: Company Research Report

Company Overview

Name: The FDA Group

• Mission of the Company: The FDA Group is dedicated to enhancing the quality of people's lives by providing top-tier talent and expertise in the life sciences, focusing on Quality Assurance, Regulatory Affairs, and Clinical Operations.

• Founded: The company was founded in 2007.

• Founder: Information about the founder is not explicitly provided.

• Key People:

• Nicholas Capman - President and Chief Executive Officer

• Matt Garrett - Chief Financial Officer

• Alan Greathouse - Head of Quality and Service Assurance

• Tara Webb - Senior Director of Account Management

• Sam Swiech - Head of Marketing

• Jason Henson - Head of Audit Project Management

• Susannah Rogers - Head of Administrative Operations

• Headquarters: 290 Turnpike Road, Suite 200, Westborough, MA 01581.

• Number of Employees: Over 3,250 resources worldwide, with more than 250 being former FDA employees.

• Revenue: No information is available

• What is the Company Known For: The FDA Group is known for rapidly providing access to highly specialized consultants, contractors, and candidates in the life sciences industry, with a strong focus on FDA compliance and regulatory knowledge.

Products and Services

Products/ Services Offered:

1. Quality Assurance

• Description: Services to build or augment QA teams and outsource QA projects to third-party experts.

• Key Features: Auditing services, remediation support, staff augmentation, FTE recruitment.

2. Regulatory Affairs

• Description: Support for regulatory filings, marketing authorizations, and maintaining compliance.

• Key Features: Regulatory submissions, staff augmentation, FTE recruitment.

3. Clinical Operations

• Description: Resourcing for clinical operations roles with specific expertise in improving clinical development and product safety.

• Key Features: Staff augmentation, FTE recruitment.

4. Commissioning, Qualification & Validation

• Description: Expertise in supporting various stages of commissioning, qualification, and validation activities.

• Key Features: Consulting projects, staff augmentation, FTE recruitment.

5. Pharmacovigilance

• Description: Detect, evaluate, understand, and prevent adverse effects in pharmaceutical and medical device products.

• Key Features: System development and maintenance, operational support, advanced consulting.

6. Expert Witness Services

• Description: Provides knowledgeable expert witnesses for FDA regulations and compliance-related cases.

• Key Features: Former FDA officials and public health experts.

Recent Developments

• Recent Developments in the Company:

• Information about specific recent developments is not provided.

• New Products Launched:

• No information is available

• New Features Added to Existing Products:

• No information is available

• New Partnerships:

• No information is available

Summary

The FDA Group stands as a pivotal entity in the life sciences sector, distinguished by its exclusive focus and expertise in supporting life science organizations. With services spanning Quality Assurance, Regulatory Affairs, Clinical Operations, among others, the company prides itself on offering rapid, reliable access to specialized consultants backed by a dedicated account management team. The FDA Group guarantees client satisfaction with a robust success rate and a Total Quality Guarantee, positioning itself as a partner dedicated to quality and integrity in life sciences.