Whether it’s a corporate needs analysis, corporate growth/transformation strategy or due diligence/acquisition, Regulatory Compliance Associates (RCA®) worldwide experience can help ensure a successful mix of top-notch advice and people so your Pharmaceutical strategy is on time, and on budget — and you’re never embroiled in a costly mistake.
As an industry leader in pharmaceutical strategy consultancy, our team has the exceptional knowledge and expertise to help you work through the challenges of pre- and post-merger integration and company growth. We offer a range of Strategic Consulting services for the Pharmaceutical industry, including:
Portfolio management allows you to determine which projects show potential and which should be abandoned — encouraging the review of all products across a portfolio to best make decisions that impact a broad product line. Regulatory Compliance Associates will help you evaluate your projects and investments using a range of portfolio management services, such as:
- Needs analysis
- Risk mitigation, partnerships and strategy alliance
- Asset evaluation
- Stage-gate governance
- R&D portfolio prioritization
Many companies fail to take time to evaluate their manufacturing processes and determine how these methods impact their bottom line. We’ll help you maximize your ROI, validate manufacturing automation and ensure compliance of aging facilities and equipment. Our services include:
- Program analysis
- Improvements in lab efficiency and throughput
- Problem-solving solutions
- Risk assessments
- Validation support for aging facilities
- Cost and waste reduction solutions
Regulatory Due Diligence
Before you move forward with a merger and acquisition (M&A) deal, you need to have a clear understanding of the associated benefits and risks. Our expertise gives us unique insight as we critically evaluate a target company’s characteristics to ensure a good fit for your business. We offer M&A and due diligence solutions including:
- Regulatory and quality due diligence
- Personnel, facility and equipment assessments
- Post-merger integration
- Risk identification
Outsourcing & Staff Augmentation
Small and large companies alike deal with staffing problems at some point in their lifetime. Whether you’re experiencing a short-term staffing issue or an unplanned crisis affecting your entire business model, we’ll craft a solution specific to your most pressing needs during this time. Regulatory Compliance Associates pharmaceutical outsourcing services include:
- Project management
- Virtual support
- Staff augmentation and temporary placement of unfilled positions
Organizational changes due to FDA compliance or evolving business needs can significantly affect the way a business is run, and these changes should be supported through a standardized change management system (CMS). Regulatory Compliance Associates will help you implement a CMS after:
- Supplier changes
- Facility upgrades
- Changes to address complaints or comply with standards
- Cost reduction initiatives
Whether you’re in the product planning, development or pharmaceutical lifecycle management stage or need a remediation strategy for a compliance crisis, RCA® will guide you through every step of the regulatory process and create a customized approach depending on your product and your pharma company’s individual needs. Our clients include:
- Companies new to FDA, Health Canada or EU regulations and the pharmaceutical industry
- Start-up organizations with novel submissions to 510(k) submissions from multi-national corporations
- Investment firms seeking private equity due diligence for pre-acquisition and post-deal research
- Law firms seeking expertise in the remediation of warning letters, consent decrees, 483’s or import bans
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.
The regulations process surrounding pharmaceutical companies can be tricky for even the most experienced industry veteran to understand, and just one misstep could mean significant and lasting consequences for your business. At Regulatory Compliance Associates, we offer the experience and resources necessary to guide you in quality compliance.
Regulatory Compliance Associates Quality consulting services include assessments, strategy, implementations, staff augmentations, and identification of quality metrics to ensure continuous improvement, aligning with your business needs and goals. Our consultants are quality experts with experience spanning major corporations and start-ups. We know firsthand how to achieve, maintain, and improve quality, and we excel in transferring this knowledge to your organization.
Regulatory Compliance Associates has helped clients from around the world develop stage-ready testing based on each product’s regulatory pathway. Our pharmaceutical testing services include supporting pre-formulation, process development for the formulation, and formulation manufacturing. The following includes a high level overview of solubility and dissolution testing, stability testing, and solid form testing we conduct for new product development clients.
Remediation Strategy & Support
Regulatory Compliance Associates has significant experience and a proven approach to managing FDA Warning Letters, Consent Decrees, Remediation, and other serious regulatory situations. We know how to partner with executive, legal, and communication teams, and will assist management with a response that will be accepted by the regulatory agency and be realistic to execute. We can develop a comprehensive proof book of documented objective evidence demonstrating the corrective actions taken to remediate non-compliant issues.
About Regulatory Compliance Associates
Regulatory Compliance Associates (RCA®) provides healthcare consulting services to the following industries for the 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. 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.
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