Drug Development Strategy

Bringing your new drug from concept to the market

Altus Drug Development can develop a strategy for the development of your new pharmaceutical compounds

Integrated Product Development Planning
Altus offers development planning and execution whatever your development stage. Altus development planning turns molecules into products. Altus works with its partners to build integrated product development plans that will provide test methods and formulations for lead molecules selection, for pre-clinical testing, for clinical testing and for product launch. Altus integrates these product development plans with patenting and regulatory plans to ensure smooth transition from Lab to Clinic to Market.
Pre-Clinical Formulation Planning
When amounts of your precious lead candidates are scarce, it’s essential to develop cost-effective and timely formulation strategies to maximize the information return from your preclinical studies. Altus will design a flexible and economic pre-clinical formulation strategy to help you make the right lead selection. Altus can also develop all the analytical methods you need.
Pre-Clinical Phase Testing
Altus will work with you to develop the primary pharmacology and second pharmacology tests you need at each stage of development to help select the best lead candidates to take forward to the clinic. Altus can manage this test program via its integrated team of Quebec and Canadian CRO.
Clinical Supply
Altus will develop your formulation for First in Human Studies and manufacture the batches you need for these and later stage clinical trials including phase III trials.
Clinical Testing
Altus can design and manage your First in Human studies with Quebec based Clinical Study Centers.
Regulatory Support
Altus can prepare for, arrange and manage your meetings with Regulatory Authorities and prepare the regulatory submissions needed for clinical testing and approval.

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FAQs about Ophthalmic Formulation
Development Services
Why have a drug development strategy?

The drug development strategy details the process followed by the new drugs, and outlines its progression through development, trials and regulatory submissions with clear steps. This strategy covers the preclinical and clinical phases, whether it is first in human trials or phase II and phase III trials.

The drug development strategy aims at answering a set of questions, which will give a clear idea of the objectives of this new drug and the best options to achieve it. It covers fundamental elements such as the end goal of the product and its desired attributes, but also locations for clinical trials, optimized clinical development and potential markets.

A strong drug development strategy is the key to fast and efficient trials and submissions, bringing your pharmaceutical product to the market as quickly and safely as possible. Mitigating your risk and achieving your goals can be greatly optimized by working with a reliable CTO.

What is a Target Product Profile (TPP)?

If the development process is the road, the TPP is the final destination of a new drug. The TPP is a list of the desired characteristics of the developed drug, such as which disease it targets and from what segment of the population. Having a clear objective allows for an optimized development with the right formulations, trials and processes. The TPP also serves as a guideline for non-clinical and clinical trials, where the right tests can be done to access the right characteristics of the new compound and make it competitive once it reaches the market.

The Target Product Profile is a constantly evolving document, which is adjusted according to the different trials and studies performed. Overseeing this important aspect of the drug’s development is a task best suited for an experienced and competent group of experts such as Altus Drug Development’s team.

What is Quality by Design in drug development?
Quality by design (QbD) is the approach used in pharmaceutical development to develop new pharmaceutical compounds. By using predefined objectives and basing itself on science and risk management in their drug development, QbD helps enterprises produce strong formulations and successful regulatory applications. As we know, pharmaceutical products are required to maintain consistent high quality, and this will stem from the design, the control of formulation and the manufacturing process. The QbD’s systematic approach is crucial to reach the newly developed drug’s planned Target Product Profile.