Your Drug Development Roadmap

Relatively small investments in preformulation tend to pay off handsomely in later stages of drug development — when any setbacks can be catastrophic.

We’ll help you:

• Minimize any problematic properties
• Reduce unnecessary testing
• Verify your API is druggable
• Increase patient compliance and commercial appeal
• Make data-driven decisions

More testing isn’t always better! One of the reasons our clients return to us again and again is that our services help them save money in the long run.

Our experts can:

• Reduce unnecessary testing without adding risk
• Help you select the most promising prototype
• Verify that your prototype shows signs of being safe and effective

Through rigorous testing, we’ll verify that your final dosage form shows every sign of being ready for clinical trial manufacturing:

• It’s consistent and sufficiently uniform
• It’s shelf-stable and sterile
• It’s commercially viable
• It has the desired release pattern
• Its protocol or flavor won’t hinder compliance

We’re literally built from the ground up to adhere to ICH and cGMP guidelines. Our quality systems are also regularly reviewed by auditors and qualified quality persons.

Here’s how that can make your life easier:

• No repeated audits are needed during European clinical trials
• It minimizes the risk of delays or rework
• Get quicker approval of your clinical trial
• Reduce unecessary waste of ingredients
• Avoid batch failures and contamination issues

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Before you get to this stage, you should make sure your risks are minimal and that your product’s quality, formulation, and packaging help you prove your case.

Here’s how we can help at this stage:

• Providing the space and specialized equipment needed for efficient manufacturing
• Avoiding problems associated with scale-up
• Producing placebos that match your protocol and increase patient compliance
• Using our connections to mitigate supply chain fluctuations

We specialize in perfecting the phases of drug development that introduce the most risk. But our tech transfer abilities can offer a faster transition than one made in-house.

Our technical transfer team will:

• Compile detailed protocols, batch records, and validation data
• Provide your manufacturer with everything they need to start production immediately
• Offer our recommendations for maintaining consistency and quality at a larger scale
• Help you avoid regulatory hurdles and accelerate your time to market