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.
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.
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.
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.
Registration Validation
Manufacture GMP batches and submit your dossier.Registration Validation
GMP production.
Finalize documentation submission.
Stability batches.
Validate the process and product.
Commercial Manufacturing
Assure reliability and continual improvement.Commercial Manufacturing
Stability batches, presentation changes, process changes, technical transfers and validation review.