Your pharmaceutical company can change millions of lives, but staff shortages among many businesses in the life science industry often make it difficult to live up to full potential. When you need to increase productivity and decrease regulatory risks, regulatory outsourcing provides an ideal solution. At Regulatory Compliance Associates® Inc., we offer a wide range of outsourced regulatory services to help you maintain your business operations — even after a compliance crisis or during a management turnover.
RCA® Inc. has the expertise to assist you with your unique regulatory needs. We understand that it’s not always submissions and inspections that companies might need assistance with, but other areas that support your business operations.
Our Statement of Work for 510(k) Submission Services is based on a reasonable, predetermined fixed fee!
RCA’s Outsourced Regulatory Services
In a competitive business world, pharmaceutical companies of any size often run lean on staff and resources. A staff shortage can slow normal business operations and make it difficult to deliver quality and timely solutions to your customers and end users. Instead, many companies choose to work with RCA for ongoing support or special projects where time and quality are of the essence.
With a team of more than 500 industry experts, RCA can offer the assistance you need through large projects and management changes. You’ll find ongoing advice and support from an array of industry insiders who can help your business flourish as you successfully navigate stringent FDA guidelines.
We can assist Interim Management situations such as: the company’s VP of Quality and Regulatory unexpectedly submits notice, or another key QA staff member takes medical leave, or the start-up company needs strategic RA / QA insights, but isn’t ready for full-time headcount. Regardless of the size of the life science company, outsourcing quality and regulatory management can bring needed expertise while saving costs. We can provide outsourced management solutions to:
- Medical Affairs
- Product Development
Perhaps you don’t need interim staff, but you’d like to teach your current staff and executives the ins and outs of regulatory affairs. We also offer a broad range of assessment, support and training services, including:
- Regulatory Gap Assessments or Regulatory Due Diligence Audits
- Change Control Support
- Regulatory Affairs Training—Proper training is key in a regulated environment. We have a training program that suits your professional needs, company goals, and preferred learning style.
- Good Manufacturing Practice (GMP) Fundamentals
- Quality System Regulation
- International Medical Device Regulations
- Good Documentation Practices
- Quality Management Systems and Infrastructure
- Management Responsibility
- Risk Management
- Complaints and Medical Device Reporting (MDRs)
- CAPA and Root Causes Analysis
- Design Control
- Environmental Control
- Calibration / Maintenance
- Purchasing Controls and Supplier Management
- Change Control
- Document Control
- Regulatory Submissions 510(k)
- Non-Conforming Product
- Technical Writing
- Adverse Finding and Consequences
- Criminal Offenses
- Contributing To A Successful Quality Culture
- Electronic Submissions Preparation in Electronic Common Technical Document (eCTD) format for FDA, Health Canada, and EMEA
Transform Your Business With Regulatory Outsourcing From RCA
Your pharmaceutical company has the power to transform lives, but you first need to stay within regulatory guidelines and maintain compliance with global regulatory authorities. If you’re looking for the best way to bring needed regulatory expertise to your business at an affordable cost, turn to the regulatory outsourcing experts at RCA.
For more than 15 years, we’ve helped thousands of companies like yours overcome staffing challenges and bring new insights into their organizations. Contact us for the regulatory guidance you need to continue making a difference in the lives of your patients.