IDIFARMA 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 focus in small batches simplifies scale up from clinical to commercial for our partners, while maximizing the yield and minimizing waste 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.
- Production of GMP intermediates through Spray Drying, including highly potent active substances.
- Comprehensive formulation development expertise helping youovercome complex formulation challenges.
- Specialty technology platforms to increase the final bioavailability of the drug product.
IDIFARMA is a specialized partner for small batches of innovative oral solid dosage forms.
It is of upmost importance to consider all the regulatory requirements of your target markets from the project start.
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 future changes to avoid expensive reworks later.
Simply to Clinic™, the best you can get for your budget.
Because we know that changes are required when you are developing, because we know that unexpected challenges may arise within your clinical stages, we have embedded in our organization the flexibility 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 Clinic™ guarantees a reliable on time in full delivery of the batches for clinical trial, ensuring quality requirements that follow GMP regulations.
IDIFARMA has successfully hosted many quality audits from official bodies and many pharmaceutical companies.
Our project management and technology transfer team use lean procedures to ensure your project runs smoothly from the receipt of your API until the delivery of product to the clinical trial site.
With the integration of all the services required for all the stages required for the clinical trial, Simply to Clinic™ is your best choice to have a single provider centralizing, minimizing risks and avoiding issues resulting of coordinating different partners.
Simply to Clinic™ is a reliable and quality-driven service brought to you by IDIFARMA.
TIME TO CLINIC FOCUS
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.
We ensure that within 1 month after receiving an RFP, you will receive a cost effective proposal including the deliverables required at each development phase.
Simply to Clinic™ provides your product ready for clinical trial within a short timeline.