Regulatory affairs is Regulatory Compliance Associates® Inc.’s backbone and we fully understand the complexities of the pharmaceutical and biopharmaceutical industries. Our expertise spans 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.
As your partner, we can negotiate the potential assessment minefield of pharmaceuticals with insight, hindsight, and the clear advantage of our breadth and depth of knowledge and experience. We offer the following four regulatory affairs services for pharmaceutical companies.
New Product Support
RCA® Inc. gives you the support and guidance you need to meet stringent industry regulations and demands as you take your new products through the research and approval process, comply with regulatory agencies, strategize in late-stage development and plan global commercialization.
Our expertise covers an extensive range of product applications with New Product Support services, such as:
- Meetings and briefings packagers, including BLA meetings, Type A, B, or C meetings, advisory meetings and more
- US and Global submissions and dossiers
- U.S. submissions — IND, DMF, BLA, ANDA, NDA — and combination products
Product Lifecycle Management
Our 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® Inc. is your go-to source for knowledgeable compliance experts throughout your product’s entire life cycle.
Our life cycle management services include:
- 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 RCA® Inc., we understand client needs are not one-size-fits-all throughout the pharmaceutical industry. We offer an array of regulatory services differentiated based on your product and unique business needs, such as training programs, dossier and submissions preparations, interim management assistance and more.
Some of the many additional 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 additional services, we offer assistance with registration and services for global pharmaceutical products you wish to sell in the U.S. As a registered U.S. agent, RCA® Inc. 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 RCA
Regulatory Compliance Associates® (RCA) provides healthcare consulting services to the following industries for 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. We are used to working on the front lines and thriving in the scrutiny of FDA and globally-regulated companies.
As your partners, we can negotiate the potential minefield of compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.
- Founded in 2000
- Headquartered in Wisconsin (USA)
- Expertise backed by over 500 industry subject matter experts
- Acquired by Sotera Health in 2021
To begin the RCA® scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage.
