In the complex and increasingly regulated pharmaceutical industry, Regulatory Compliance Associates® Inc. can assist you with new product development regulatory support. From early development stage and seeking guidance for FDA meetings, to later stage regulatory strategy and global alignment of submissions and dossiers, RCA is your one-stop source for regulatory expertise. We have over 500 global pharmaceutical consultants who provide services to support all types of new product applications.
Pharmaceutical New Product Development
- Global Regulatory Strategy
- Regulatory Strategy for Drugs
- Domestic and International Establishment Registration
- Submission Authoring and Review, including:
- New Drug Applications (NDAs)
- Generic Drug Applications (ANDAs)
- Drug Master Files (all types) (DMFs) and the European Pharmacopoeia and Certificates of Suitability (CEPs)
- Marketing Authorization Application (MAA) Clinical Reviews
- Follow-up and Question Resolution
- Audit Support
- Meetings and Briefings Packagers
- Biologics License Application (BLA) Meetings
- Type 8 Meetings
- Pre-Investigational New Drug (Pre-IND)
- End of Phase 2
- Pre-New Drug Application (Pre-NDA)
- Advisory Committee
- Orphan Designation (Formal Designation Request)
- Submissions
- Drug Substance, Drug Product, Manufacturing, Labeling, Container Closure Supplier Requirements, Quality Assurance
- Generic Drugs
- Labeling for U.S. Submissions
- Structured Product Labeling (SPL) Requirements and Analysis of Innovator Labeling
- Side-by-Side Comparison
- Assistance with “Carve-Outs” Related to Patents
- SPL not Required at IND Phase has Nothing to do with SPL Labeling
- NDA: 505(b)(1) & 505(b)(2) and NDAs
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
- Headquartered in Wisconsin (USA)
- 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.
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