Cannabis Regulation
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From the legalization of recreational marijuana to the growing popularity of CBD-infused products, the cannabis industry is all abuzz in the United States. What does Cannabis regulation look like? In this episode of RCA Radio, host Erika Porcelli and guest Neil Pankau discuss this burgeoning industry, the regulatory framework governing it, anticipated regulatory developments at the federal and state level, and the FDA’s likely path on oversight.
Listen in as we break down key terminology, discuss the impact of cannabis regulation. examine the controls and cannabis regulation businesses should consider whether new or entering the industry, and share our thoughts on the future regulation and sale of these products.
About RCA’s Regulatory Consulting Services
Regulatory affairs is Regulatory Compliance Associates 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, 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
- Cannabis Regulation
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 Regulatory Compliance Associates
Regulatory Compliance Associates (RCA) provides regulatory compliance consulting to the following industries:
- Life Sciences
- Pharmaceutical
- Biologic & Biotechnology
- Sterile compounding
- Medical device
- Lab Testing
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.
