Striving to Assist You with Your Unique Regulatory Strategy

We have experience with suspensions, solid dosages, topicals, and liquid and lyophilized parenteral products. We have worked with North American, European, South American and Asian regulatory bodies, and with international standards such as ISO, ICH, and multiple pharmacopeial requirements.

How can CMC Turnkey Solutions assist you with your journey?

Drug Discovery

Start the process with future commercial success in mind.

Drug Discovery

Provide guidance for API selection.
Select the right vendors for your studies.
Set your sights on your future specifications.

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Preclinical Proof of Concept

Head toward clinical trials with confidence.

Preclinical Proof of Concept

Select the right quality for your API and excipients.
Select vendors for manufacturing.
Select and refine test procedures.

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Phase I /Phase II

Put together the best strategy for early clinical trial phases.

Phase I / Phase II

Formulation development.
Phase-appropriate test procedure qualification.
Specification setting.
Presentation change and finalization.

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Phase III /Phase IV

Finalize your strategy and prepare for successful submission.

Phase III / Phase IV

Identify critical process parameters.
Set process validation strategy.
Validate test procedures.
Finalize submission strategy.

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Registration Validation

Manufacture GMP batches and submit your dossier.

Registration Validation

GMP production.
Finalize documentation submission.
Stability batches.
Validate the process and product.

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Commercial Manufacturing

Assure reliability and continual improvement.

Commercial Manufacturing

Stability batches, presentation changes, process changes, technical transfers and validation review.

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Connect with us.

Please contact us with your questions and needs. Describe your situation and let us help you stay on the path for success.

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