Simply to Clinic™

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CMC tips for a seamless path to clinic

Your complex drugs, simply delivered

 

IDIFARMA introduces Simply to Clinic, accelerating your complex products to clinic with deep expertise.

We are your perfect partner for the development and GMP manufacture of your innovative products for clinical trials.

Simply to Clinic™ leverages the technologies and expertise gained by IDIFARMA across its support of many clinical trials of oral solid dosage forms over 20+ years.

From pre-formulation through to commercial, we offer tailored services under one roof to develop, scale and manufacture your product.

Our specialism in small batches simplifies scale up from clinical to commercial for our partners during clinical stages, while maximizing the yield and minimizing loss of your precious API.

We streamline your path to clinic with deep expertise in:

• Handling highly potent active substances, a very common feature in oncology products.
• Specialty formulation technology platforms to increase the bioavailability of the drug product.
• Production of GMP intermediates through Spray Drying, including highly potent active substances.
• Clinical supply management, including bespoke design, printing and assembly ensuring on-time delivery.

Regulatory Compliance

We create a regulatory roadmap from the earliest development stages to anticipate all relevant CMC issues and avoid significant delays and unexpected extra costs in your path to the clinic and later to the market.

Additionally, all our GMP activities consider not only current GMP guidelines but also upcoming changes to avoid expensive reworks later.

Simply to Clinic™, ensuring a safe and efficient regulatory path.

 

Flexibility

Because we know that flexibility is required during development and that unexpected challenges may arise within your clinical stages, we have embedded in our organization the agility and knowledge required to adapt our technological solutions at your convenience.

Our flexibility is our guarantee to improve and overcome all unexpected events without impacting the time to reach the clinical milestones.

Simply to Clinic™ provides flexible and innovative solutions for challenging projects.

 

Right First Time

Idifarma has an outstanding track record of perfect clinical supply that speaks for us.

Simply to Clinicguarantees a reliable on time in full delivery of the batches for clinical trial, ensuring quality requirements that follow GMP regulations.

Our project management and technology transfer team use lean procedures to ensure your project runs smoothly from the receipt of you API until the delivery of product to the clinical trial site.

Simply to Clinic™, top quality from bench to bedside.

 

Fast to Clinic

Finally, Simply to Clinic solution provides a streamlined process that can reach the clinic in as little as 15 weeks.

Our solution even includes stability data (1-3 months), assuming availability of analytics development and raw materials for a phase I clinical study.

Simply to Clinic™ accelerates your drug development and manufacturing through to clinic.

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