Customisable and tailored consultancy

Thanks to our considerable worldwide experience, DOC can offer a wide range of consultancy services. These are specifically targeted towards troubleshooting, gap analysis and recovery for existing facilities and processes. Our aim is to help clients maintain compliance as regulatory requirements are modified, or to compensate for weak current situations.

Consultancy Services

With more than 25 years' experience gained from collaboration with leading firms, and relevant regulatory agencies and organisations, DOC can offer a proven range of consultancy services. Our qualified teams can mitigate risk, and respond to crisis or the regulatory changes that might have an impact on your business, for example, approval delays, recalls and deficiencies.

DOC can offer the following consultancy services:

• Contamination Control Strategy: according to Annex 1, gap analysis, definition of all critical control points and assessment of the effectiveness of all the controls (design, procedural, technical and organisational) and monitoring measures employed to manage risks to medicinal product quality and safety.
• Process Validation: process design, risk assessment to identify and establish critical parameters, data collection and evaluation, protocol and report issue. 
• Aseptic Process Simulation: identification of the worst case conditions to be applied for validating the aseptic process. Evaluation of the impact that the introduction of a new product has on the aseptic process validation (APS) validated in aseptic manufacturing processes. 
• Risk Assessment (Nitrosamine): to evaluate the potential risks that may contribute to N-nitrosamine impurities generation during product manufacturing and storage. With this purpose, the applicability of the available data supplied by the vendors of raw materials, in-process equipment, cleaning agents and primary packaging are evaluated. These data are used to determine the possibility and/or the need of one or more specific actions to mitigate risk of presence of N-nitrosamine impurities during product manufacturing and storage. 
• Risk Assessment (elemental impurities): to identify, analyze and evaluate the potential risks that may contribute elemental impurities during product manufacturing and storage. Potential sources of elemental impurities are identified and data available analyzed and processed to predict the level of each elemental impurity into the final drug product. A comparison with their proper permitted daily exposure is used to determine the need of a risk reduction plan. 
• Risk Assessment (E&L): to identify, analyze and evaluate the potential risks on the final product quality in terms of extractables and leachables coming from the in-process materials in contact with the specific product according to the approach given by ICH Q9 “Quality Risk Management”. The implementation of a plan for risk reduction is evaluated basing upon the applicability of extractables and leachables data available. 
• Extractables assessment: to evaluate the extractables compounds that can be potentially a toxicological concern in terms of patient safety, product quality or purity beyond the official or other established requirements taking into account all the in-process materials involved (also coming from different suppliers). 
• Toxicological Assessment: to assess the Permitted Daily Exposure (PDE) value of chemical compounds using the available methodologies and toxicological data coming from literature search. The assessment is performed by recognized toxicologist. 
• Cleaning Validation: to investigate the suitability of specific cleaning methods on manufacturing surfaces. The validation of suitability of the sampling method (swab or rinsing) has the scope to further verify the absence of residues on the equipment surfaces that could be carried out to the next batch in production line.