Regulatory Due Diligence Services
Regulatory issues arise unexpectedly and can create significant strain on a company’s resources. As such, it is advisable for all companies to carry out regular and frequent regulatory due diligence and regulatory audits. Speedily identifying risk factors and efficient methods of risk assessment are key in order to avoid any unexpected regulations or setbacks that could have severe consequences on the business.
Mergers & Acquisitions may lead to the discovery of an inconsistency within the product line or business which could significantly decrease its value – this could include incomplete authorization processes, inadequate labeling process or non-compliant products with regulators open points. Merger & Acquisition, product acquisition, purchasing drug substance and/or drug products and 3rd party suppliers of contracting-in manufacturing services require very high levels of review of target companies/suppliers to determine their technical capability, availability of regulatory services documentation and for the data they generate.
DDReg helps provide the single window with experienced hands and subject matter expertise of performing out due diligence to assess.
- Technical capabilities and regulatory framework of target companies
- Regulatory manuscripts on Finished Dosage forms & APIs of the target brands or companies
- Overall regulatory & quality capabilities of API suppliers and contract manufacturers
- Regulatory compliance of third-party manufacturers within & outside of India
Basics of Regulatory Due Diligence for Product Development
Regulatory affairs due diligence is an important aspect with respect to ensuring that an organization is compliant with industry-specific regulations whilst mitigating potential risks and facilitating business practices and operations that are sustainable. The process of conducting regulatory affairs due diligence constitutes meticulous and thorough examination & review of how well the organization is adhering to the applicable laws, regulations, and standards that governs its operations.
A regulatory affairs due diligence checklist is critical in ensuring the systematic evaluation of multiple components regarding compliance. This checklist may serve as a structured guide which covers critical elements including legal requirements, quality assurance, and strategies for risk mitigation. By scrutinizing these key aspects, pharmaceutical companies can efficiently identify and address any regulatory pitfalls that may potentially affect the business. Several initiatives can benefit from this process, ensuring that regulatory considerations are integrated into strategic decision-making.
The process of regulatory due diligence goes beyond compliance as it significantly contributes towards management of reputation within the industry, financial prudence, and even an organization’s adaptability with respect to dynamic and ever-changing regulatory landscapes. In order to efficiently operate on a global level, it is imperative for pharmaceutical organizations to have a deep and nuanced understanding of the evolving regulatory environments. They should also have a robust due diligence mechanism that helps navigating regulatory complexities. Regulatory due diligence is a proactive strategy that addresses compliance challenges and supports regulatory excellence by aligning pharmaceutical businesses with applicable requirements & standards for long-lasting success.