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REGULATORY PLANNING & REMEDIATION
The "rule book" that companies have to "play by" is one that has been imposed upon the regulatory affairs professional by many outside/external organizations (FDA, EMEA, FTC, CBP, SEC, Sarbanes Oxley etc) - specifically, the world's many and diverse regulatory authorities responsible for approving new drugs for sale in their geographies. It is not surprising that corporate milestones mirror regulatory activities. Regulatory builds and manages timelines to achieve strategic goals along the development continuum: filing clinical applications, filing & obtaining orphan drug or fast track designation etc. These milestones are all equated with how well the business is achieving its goals and meeting projections; they are the metrics for quantifying and qualifying corporate success in the healthcare products industry. Importantly, these milestones are pivotal events for company valuation especially in a M&A situation.
- Design Effective Regulatory Strategy to ensure success
- Improved profitability and investor confidence with less FDA sanction and product recall risks
- Implement consistent and repeatable compliance programs applicable to any regulation or operating standard
- Enable effective integration of business processes and technologies supporting regulatory activity
Clarkston's Regulatory Planning & Remediation solution addresses four strategic areas:
Regulatory Strategy
More than any other discipline in healthcare product development, regulatory is integral to the healthcare product lifecycle from strategic planning to pre-market approval to post-market approval. Squandered regulatory opportunities can result in missed markets and reduced profit potential where sales are not optimized. Effectively designing a comprehensive regulatory strategy can help ensure success. Strong regulatory strategies in parallel with development of new formulations/doses, second and third generation compounds, new indications, patent extensions and market exclusivity determine a product’s longevity and continued revenue stream.
The foundation of a sound strategy rests on a deep understanding of the data and also the potential deficiencies that can undermine the development program. Whether the product is indigenous or in-licensed, a proper due diligence exercise will uncover areas of risk that the regulatory leader is obligated to review with management before financial and operational commitments are put into effect. Go/No-go decisions are made from this exercise. Our services include identifying and quantifying regulatory risks and exposures and providing recommendations to resolve issues that could be potential deal breakers or makers.
Mergers & Acquisitions continue to pose a very attractive path for corporate growth. Companies planning to expand via M&As should ensure that they have solid post-integration strategies in place and suitably qualified staff in sufficient numbers to enable a solid transition and minimize operational risks. Post-integration operations could involve the transfer of product licenses from one company to another. Since registration procedures normally have relatively long lead times, a rigorous plan needs to be developed and implemented. Lack of a proper transfer strategy could lead to loss of licenses or out of stock situations. Services that help clients maximize the synergies gained through a merger or acquisition. Through our work, our clients align the people, processes and technologies of the combining organizations to achieve a smooth transition and the greatest possible value from the merger or acquisition.
Regulatory Compliance
Effective compliance programs are the key to successful product launches and increased revenue. Within a single organization there may be many areas that deal with some form of compliance – ie Finance with the SEC, Accounting with Sarbannes-Oxley, Marketing with HIPAA, etc. Ironically, each area is performing the same set of steps and has very similar controls in each area. One of our strategic services is the implementation of a Compliance Program Office to coordinate all compliance efforts across and organization. Our regulatory planning and remediation solution helps pharmaceutical companies identify root causes and implement programs that will increase Right First Time percentages, prepare for internal audits and assist with 483s, warning letters, and consent decree challenges.
Regulatory Systems Implementation
The role of regulatory affairs is critical in ensuring successful product registration in each market. However, as the number of products, updates, variations, and potential markets increase, full control of these registration activities is becoming increasingly complex. Companies need to ensure that adequate business processes and technical solutions are in place to enable regulatory affairs professionals to access the relevant data to perform impact assessments etc. Our services include business process assessments, vendor assessment & selection and technology implementation.
Regulatory Intelligence Monitoring
It is critical for an organization to know and understand the requirements for product registrations in the countries in which they want to market their products. It can be an overwhelming task for regulatory affairs professionals to keep abreast of the requirements and new initiatives (SPL, PIM, eCTD etc) being proposed by regulatory bodies and the resulting impact on their organizations. Clarkston's Statutes and Regulations Center of Excellence monitors emerging regulatory requirements and their impact on our clients in this dynamic regulatory landscape.
Clarkston delivers:
- Regulatory Strategy
- Regulatory Due-Diligence
- Industry benchmarking
- Roadmap development
- Organizational effectiveness
- M&A Support
- Regulatory Compliance
- Program Management Office (PMO) and Compliance Program Office (CPO)
- Gap Analysis / Risk Assessment
- Verification & Mock Audit Assistance
- Remediation & Action plans
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