A dedicated team offering a wide range of services.

At DOC, our global offering isn't just limited to the qualification of equipment and systems. Thanks to a dedicated team of project managers, who are all biologists and biotechnologists with considerable experience in the field, we can offer a wide range of services that include the development and validation of sterile and non-sterile processes, up to the qualification of pharmaceutical and cosmetic finished forms.

In all these enterprises, DOC is capable of handling any kind of product formulation, from the Active Pharmaceutical Ingredients (APIs), through to cytotoxic and controlled drug substances and their precursors.

Our Process Validations take into consideration the reproduction of the actual manufacturing operation, from the small scale of clinical and R&D processes, to long and complex process campaigns.

Our Project Management assistance includes:

• a-Logistic arrangement.
• Study approach definition in compliance with the specific regulatory requirements.
• Elaborate and development protocols and/or the necessary documentation.
• Plan, monitor timelines and supervise project execution.
• Provide regular updates.
• Laboratory raw data collection, review and interpretation.
• Out of specification support, troubleshooting, trends, etc.
• Support to regulatory inspection/audit (if requested).

The division provides validation and qualification services focused in the following areas: 

• Process validation
• Primary, secondary and tertiary packaging
• Finished pharmaceutical product

Process validation 

Our validation meets the international regulatory compliance requirements.

DOC conducts validation for both new and existing processes. This is in case there have been improvements or changes made in particular manufacturing processes. Our study approach meets the international regulatory compliance requirements for process validation. Each process validation will vary in its scope, based on the reason for the validation, and the importance and complexity of the process and the equipment involved.

Focusing on pharmaceutical and cosmetic liquid applications, DOC is able to offer the following validation services:

• Process Qualification Study 
• Process Optimisation Study 
• Product and Process Filter Validation 
• Cleaning Validation 
• Validation for the packaging