Regulatory Affairs

Regulatory affairs is Regulatory Compliance Associates (RCA®) backbone and we fully understand the complexities of the pharmaceutical industry and biotechnology industry. Our team of regulatory consultant Experts span all facets and levels of Regulatory Affairs, from Regulatory Support for New Products to Life Cycle Management, to other services like Outsourced Regulatory Affairs, Submissions, Training, and more.


Regulatory Consulting Services


As your regulatory consultants & partner, Regulatory Compliance Associates can negotiate the potential assessment minefield of pharmaceuticals with insight, hindsight, and the advantage of management consulting experience. We offer the following four regulatory affairs services for pharmaceutical companies & pharmaceutical science organizations.


New Product Support


Regulatory Compliance Associates gives you the industry guidance and regulatory consultants you need to meet stringent new product regulations. While other consulting firms have good ideas, RCA’s regulatory consultant Experts can support your new products through the research and approval process to comply with regulatory agencies. Our regulatory consultants can help your leadership team strategize about late-stage development and strategic consulting for global commercialization.


Our regulatory compliance consulting expertise covers an extensive range of regulatory agencies & product applications with New Product Support services, such as:

  • Regulatory meetings and briefings packages
    • BLA meetings
    • Type A, B, or C meetings
    • Advisory meetings
  • Health Canada, MHRA, and global submissions or dossiers
  • U.S. FDA submission — IND, DMF, BLA, ANDA, NDA — and combination products


Product Lifecycle Management


Our regulatory consulting team of seasoned experts can serve your needs, even if your product is already on the market. Whether you need dossier content management, a regulatory strategy or experts to assist with transitional periods in your business, RCA® is your go-to source for knowledgeable compliance experts throughout your product’s entire life cycle.


Our Regulatory Compliance Associates Expert consulting life cycle management services include:

  • Pharmaceutical research
  • Staff Augmentation
  • Dossier/application management
  • Global change control
  • GMP’s for early-stage development
  • eCTD and Electronic Submission Capabilities to the U.S., Canada, and the EU


Other Regulatory Services


At Regulatory Compliance Associates, we understand client needs are not one-size-fits-all throughout the pharmaceutical industry. We offer an array of regulatory services differentiated based on drug companies and unique medical consulting. Our regulatory consultants lead training programs, dossier and submissions preparations, interim management assistance, and more.


Some of the many additional regulatory compliance consulting services we offer include:

  • Outsourced regulatory services
  • New dossier and DMF or conversion to eCTD
  • Electronic eCTD preparedness and submission
  • Regulatory affairs training
  • Site Registrations


U.S. Agent Services


As part of our regulatory consultant services, we offer assistance with registration and services for a global pharmaceutical drug you wish to sell in the U.S. As a registered U.S. agent, Regulatory Compliance Associates will expertly handle FDA interactions for international companies selling imported drugs.


Our role as a U.S. agent allows us to:

  • Assist with FDA communication on a foreign company’s behalf
  • Answer questions about the drugs being imported into the U.S.
  • Aid in scheduling FDA facility inspections


About Regulatory Compliance Associates


Regulatory Compliance Associates (RCA) provides pharmaceutical consulting & regulatory compliance consulting to the following industries for the resolution of compliance and regulatory challenges:



We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. Our life science consultants are used to working on the front lines and thriving in the scrutiny of FDA, Health Canada, MHRA and globally regulated companies.


As your partners, we can negotiate the potential minefield of regulatory compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.


  • Founded in 2000
  • Expertise backed by over 500 industry subject matter experts
  • Acquired by Sotera Health in 2021


About Sotera Health


The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.


Sotera Health Company, along with its three best-in-class businesses – Sterigenics®Nordion® and Nelson Labs®, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.


We are a trusted partner to more than 5,800 customers in over 50 countries, including 40 of the top 50 medical device companies and 8 of the top 10 pharmaceutical companies.



To begin the Regulatory Compliance Associates scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 



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