Company profile: Regulatory Compliance Associates
1.1 - Company Overview
Company description
- Provider of regulatory and quality consulting services for medical devices, pharmaceuticals, biologics, and compounding pharmacies. Offerings include regulatory affairs and submissions, compliance assurance, quality services, remediation strategy, FDA inspection preparation, cGMP guidance, and lab testing (biocompatibility, toxicology, sterility assurance, stability) to support product development and lifecycle needs.
Products and services
- Regulatory Affairs: Handles regulatory submissions and compliance for medical devices, pharmaceuticals, and biologics, ensuring adherence to global regulations, enterprise-grade
- Medical Device Consulting: Engineers regulatory pathways for devices, delivering regulatory affairs support, compliance assurance, quality services, and remediation strategy to navigate the regulatory process, industrial-grade
- Pharmaceutical Consulting: Constructs regulatory compliance frameworks and quality assurance programs while offering strategic consulting to address industry challenges in pharmaceutical operations, enterprise-scale
Key contacts
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Financial details
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1.2 - Competitors and similar companies to Regulatory Compliance Associates
Inamed
HQ: Germany
Website
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- Rationale: This competitor operates in a highly similar market segment with overlapping features.
- Company type: Private company
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- Total funding raised: $●●●m
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Absorption Systems
HQ: United States
Website
- Description: Provider of research tools developed and implemented to help customers better predict human outcomes, serving a wide variety of pharmaceutical and biotech industry customers, including small virtual pharma companies; with locations in Exton, Pennsylvania; San Diego, California; and Panama City, Panama.
- Rationale: This competitor operates in a highly similar market segment with overlapping features.
- Company type: Private company
- Employees: ●●●●●
- Total funding raised: $●●●m
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Gubra
HQ: Denmark
Website
- Description: Provider of pre-clinical contract research (CRO) services and proprietary early target and drug discovery programs focused on the metabolic space, including obesity, diabetes, NASH, and diabetic complications, with specialization in in vivo pharmacology.
- Rationale: This competitor operates in a highly similar market segment with overlapping features.
- Company type: Private company
- Employees: ●●●●●
- Total funding raised: $●●●m
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Qointa
HQ: Belgium
Website
- Description: Provider of a compliant, validated eHealth platform for device-agnostic patient monitoring and coaching, enabling direct randomization into adaptive clinical trials. Offers digital transformation and software validation solutions, quality and regulatory support (QMS and risk management), medical device software development, and electronic data integrity services.
- Rationale: This competitor operates in a highly similar market segment with overlapping features.
- Company type: Private company
- Employees: ●●●●●
- Total funding raised: $●●●m
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Envigo
HQ: United Kingdom
Website
- Description: Provider of essential products and research services to pharmaceutical, crop protection, and chemical companies, as well as universities, governments, and other research organizations.
- Rationale: This competitor operates in a highly similar market segment with overlapping features.
- Company type: Private company
- Employees: ●●●●●
- Total funding raised: $●●●m
- Backers: ●●●●●●●●●●
- Acquisitions: ●●
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2.M&A buyers
2.1 Potential strategic acquirers in the sector
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2.2 - Strategic buyer groups for Regulatory Compliance Associates
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3. Investors and private equity firms
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2.2 - Growth funds investing in similar companies to Regulatory Compliance Associates
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4 - Top valuation comps for Regulatory Compliance Associates
4.2 - Public trading comparable groups for Regulatory Compliance Associates
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