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Regulatory Compliance Associates

Helping companies successfully resolve complex regulatory challenges within the life science industry

100% Client Focused

The Regulatory Compliance Associates® team of life science consultants from FDA-regulated industries has regulated the front lines in regulatory affairs, compliance assurance, quality assurance, remediation strategy and support, and strategic consulting. Not only do we understand the complexities of running a life science business, we can also negotiate the difficult demands of remediation and compliance with insight, hindsight, and the clear advantage of our unique expertise and experience.

As your partner, we ensure you receive the highest level of satisfaction on every single project. We know how to get things done with quality results, on time and on budget. We also believe the journey–how we engage with you through this process–is every bit as critical to achieving a successful outcome.

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What We Do

Regulatory Affairs

From regulatory support for new products to life cycle management to other services like outsourced regulatory affairs, submission, training, and more.

Compliance Assurance

Guidance for assessments, audits, regulatory agency response, preparation and training, and inspection readiness.

Quality Assurance

Assessments, strategy, implementations, staff augmentations, and identification of quality metrics to ensure continuous improvement, aligning with your business needs and goals.


Regulatory action, consulting and manufacturing support to remediate 483 observations, warning letters, untitled letters, and consent decrees.


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Why Choose Us?

  • RCA is widely recognized within the life science industry and among global regulatory agencies for its ability to help companies successfully resolve complex regulatory challenges.
  • By mining regulatory intelligence, RCA continuously evaluates FDA’s current practices and leverages thought leadership networks to advocate for our clients.
  • We know a quality or compliance crisis can significantly impact your business. We have the experience to manage them.
  • We have the know-how and proven approach to navigate warning letters, consent decrees, and other situations.
  • We excel in partnering with your executive, legal and communications teams.
  • We help navigate the storm and manage the impact to your business.

Global Code of Conduct

Our entire RCA & Nelson Labs team is committed to offering impartial,
unbiased advice to clients to maintain the integrity of the services
we offer.

Read Our Global Code of Conduct