Strategic Planning Services

Pharmaceutical Product Design

Although you know your drug and you know your market you may not know the best way to deliver your drug to reach its commercial goals. Altus can design and deliver;

  • New Formulations of well-established drugs with unique features allowing market differentiation and price premiums. Altus Value Added Medicines come with patent coverage exceeding market exclusivity.
  • First in Man Formulations conceived, developed and provided for pre-clinical studies, GLP studies and rapid and cost-effective progress through clinical studies. We also manufacture clinical supplies for all phases of clinical testing.
  • Enabling Formulations. Technology based formulations for difficult to deliver drugs including poorly soluble and insoluble drugs.
  • Protective Formulations. Providing patent protection for NCE lacking patent coverage.

Drug Development Financial Strategy

Tax Incentives for pharmaceutical development

Altus Drug Development, with its unique position within Quebec, Canada can reduce the cost of your development program by leveraging tax credit advantages not seen in other countries or provinces.

Grant Incentives for your clinical and nonclinical trials

Altus can help with new grant applications to support your primary pharmacology, secondary pharmacology, and safety pharmacology testing.

Pre-Clinical Formulation Planning
When amounts of your precious lead candidates are scarce its essential to develop cost-effective and timely formulation strategies to maximize the information return from your pre-clinical studies. Altus will design a flexible and economical pre-clinical formulation strategy to help you make the right lead selection. Altus can also develop all the analytical methods you need.
Pre-Clinical 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.
Lead Characterization
Lead selection is not just about potency. The relative solubility, permeability and stability profiles of your lead molecules are also a key deciding factors in your selection of a lead candidate. Altus, with its expert analytical and chemistry teams, will prepare your lead candidate API characterization plan to give you the physicochemical, permeability and stability data needed to support lead selection.
IND Enabling Studies
A large body of in vitro and in vivo performance data is essential by the time you invest in GLP toxicology studies. Altus will collect these data, provide your toxicology and Ph I formulation and manage your IND enabling study program.
Clinical and Commercial Manufacturing
Altus via its global CMO partners can prepare a process and methods transfer plans to ensure your product is manufactured and supplied where you need it and on-time

Regulatory Planning and Submission Strategy

Regulatory intelligence and regulatory planning are essential to efficient and cost-effective product development. Regulatory planning means more than reading the guidance.

Altus provides a full range of regulatory planning and execution services from initial regulatory assessment through IND enabling study planning, dossier development and submission, clinical submission meeting planning and in-person support.

Patent Strategy for you pharmaceutical products

Products have a life-cycle and Altus’ provides, supports and executes, a patent strategy for all of them. For NCE and NME lacking patent coverage for extended market exclusivity Altus Patent Umbrella can provide protection.