Regulatory Compliance Associates (RCA®) expertise in pharmaceuticals extends to existing products on the market. We can help with regulatory strategy and dossier content management throughout your entire product lifecycle, including over 500 global pharmaceutical consultants with the expertise to support your team.
Product Lifecycle Services
- Annual Reports and Periodic Adverse Drug Experience Reports (PADERs)
- Changes Being Effective: CBE-0 and CBE-30 Supplements
- Prior Approval Supplements (PAS)
- Amendments
- Drug Master File (DMF) or Legacy Application Conversion to Electronic Common Technical Document (eCTD) Format
- eCTD Publishing Capabilities to Meet Agency Publishing Requirements
- Type 1 and Type 11 Variations (EU)
- Gateway / Portal Access for Submissions to FDA, Health Canada, and EMEA
About Regulatory Compliance Associates
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, 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.
