Whether it’s a corporate needs analysis, corporate growth/transformation initiative or due diligence/acquisition, Regulatory Compliance Associates (RCA®) worldwide experience can help ensure a successful mix of top-notch advice and people so your strategy is on time, and on budget — and you’re never embroiled in a costly mistake.
Follow the links below to learn more about our strategic consulting services in Pharmaceuticals and Medical Devices.
|
|
|
Regulatory Compliance Associates has significant quality and regulatory compliance consulting experience and a proven regulatory framework for managing FDA 483’s, Warning Letters, and Consent Decrees. Our pharmaceutical consultants know how to partner with executive, legal, and communication teams at all levels of a life science company. RCA’s remediation consulting experts can assist your management with a remediation strategy that is accepted by the regulatory agency and realistic to execute internally. Finally, RCA can partner with your leadership team to develop a long-term risk management plan to help your team stay in compliance going forward.
Regulatory Compliance Associates can assist with answering FDA 483 observations, FDA Warning Letters and developing strategies to help your organization maintain regulatory compliance through continuous improvement.
RCA can help with remediation activities in both manufacturing operations & quality management systems. RCA’s regulatory consultants have completed many projects assisting our clients to evaluate what is needed, collaboratively determine action plans & help execute. We have also performed post-implementation audits to ensure regulatory compliance.
Follow the links below to learn more about our remediation services in Pharmaceuticals and Medical Devices.
|
|
|
Increasingly, life science companies are feeling the pressure of greater scrutiny by regulators and responding by developing sustainable compliance strategies. Whether it’s preparing for an audit or developing a response to an FDA finding, Regulatory Compliance Associates® team of compliance consultants can help. Our business consultant Experts are internationally known in the regulatory compliance consulting industry.
The regulations process surrounding life science companies can be tricky for even the most experienced compliance veteran. If you’re consistently unable to comply with regulations, any notified body can deliver devastating consequences for your business. At RCA®, we offer the management consulting resources necessary to guide you in regulatory compliance.
Follow the links below to learn more about our compliance assurance services in Pharmaceuticals and Medical Devices.
|
|
|
Regulatory Compliance Associates (RCA)® has helped thousands of pharmaceutical companies meet regulatory, compliance, quality assurance, and remediation challenges. With more than 20 years of experience with FDA, Health Canada, EU and global regulatory agencies worldwide, RCA offers leading pharmaceutical consultants that can help you navigate through the challenges associated with evolving industry regulations.
We also handle more medical device regulatory affairs consulting submissions in a month than many manufacturers do in a lifetime. We have experience working with the FDA, MHRA, EMA and notified bodies worldwide. Therefore, you can count on RCA’s medical device regulatory consulting for in-depth and up-to-date insights which increase speed-to-market.
Let the RCA team of experts guide you through the constantly changing domestic and international regulations to successfully register your products. From pre-submission strategies to international submission support, our expert team has the unique insight necessary to help you take your products to the next stage of product development.
Follow the links below to learn more about our regulatory services in Pharmaceuticals and/or Medical Devices.
|
|
|
Our consultants provide our clients with practical solutions for any size business. They have the knowledge and experience to develop, implement, and maintain quality and regulatory compliance solutions with quality results, on time and on budget. Our experts are a strategic blend of Ex-FDA Inspectors and Reviewers, industry veterans and experienced specialists. Support for everything from new product development to an agency action, RCA can assemble the right team for any project.
In the life science industry, quality assurance (QA) is more than merely ensuring the quality of a finished product. You need the tools to monitor and regulate every process from the design of a new product to continued quality compliance as the device or drug is sent to market. At Regulatory Compliance Associates (RCA), we offer you the quality assurance services you need to monitor these quality processes and ensure quality compliance every step of the way.
RCA’s quality assurance services include quality system assessments, strategy, implementations, and identification of quality metrics. Our quality consultant projects are designed to ensure continuous improvement and align with your business needs & goals. Our quality consultants are quality experts with experience spanning major corporations and start-ups. Our quality management consultant team knows firsthand how to achieve, maintain, and improve quality, and we excel in transferring this knowledge to your organization.
Follow the links below to learn more about our quality assurance services in Pharmaceuticals and Medical Devices.
|
|
|
