Dossier compliance assessment is a key activity in product registration. It plays an important role in the process both prior to dossier submission and during the review cycle. Enabling the manufacturer to implement a risk mitigation plan based on the open points addressed by pharmaceutical and regulatory experts. ACCESTRA provide elaborate dossier compliance assessment for drugs, APIs, pharmaceutical excipients and packaging materials. Our assessment can minimize the risk of rejection, avoid format deficiencies and possible delays in the review cycle for your product registration. The approval process will be accelerated, and you will obtain the ultimate market approval for a minimized budget.
Please contact us for more information about the following service:
- Regulatory Gap Analysis
- Registered Dossier Gap Analysis
- e-CTD Conversions