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 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 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