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.
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
Our team of seasoned experts can serve your regulatory affairs 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 regulatory 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
At RCA® Inc., we understand regulatory 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
As part of our additional regulatory 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