Drug Development Services

We help to bring your drug from idea to patient

Efficacy and safety are two cornerstones of drug development. But drug development is hard work. Ensuring drug efficacy (does the drug, for example, lower blood pressure as it is supposed to do?) and safety (unwanted side effects) relies on a well-structured process with the highest quality in mind.

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What characterizes a well-structured process? Doing the right things at the right time. Doing so will enhance your chances to obtain good study results regarding efficacy and safety and, reduce the risk to get poor study results and a drug formulation that is not up to par with your claims.

Moreover, a flawed toxicology study can result in prolonged animal testing which, in turn, extends the time before your first-in-human trials. So, there’s a reason why quality, efficacy and safety, should take top priority for pharmaceutical companies

Areas of expertise 

SDS Life Science expertise spans the whole drug development journey, from idea to patient. Whether it is small molecules or biologics including vaccines, new modalities, or advanced therapy medicinal products (ATMP), SDS Life Science can lead and coordinate the way. We can help with formulation development to the design of non-clinical programs, from regulatory strategies and clinical study designs.

 

 

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Toxicology - Services for safety and risk assessment

Toxicology is about identifying and studying adverse effects. SDS Life Science can take an advisory role in planning, preparation, monitoring and reviewing toxicology and safety pharmacology studies in drug development.
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Pharmacology, metabolism and pharmacokinetics (DMPK)

Pharmacology and pharmacokinetics is the scientific field that studies how the drug affects the body and how the body handles the drug. It concerns the wanted and unwanted effects and absorption, distribution, metabolism, and excretion of substances. Our experts support in advising, planning, analyzing, writing and reviewing clinical pharmacology and DMPK programs and studies.
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Target Product Profile (TPP)

Drug development requires a clear and effective strategy that addresses the needs of investors, regulatory agencies, and your development team. Without a well-defined target product profile, you risk losing precious time and resources on ineffective or misaligned strategies.
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Pharmaceutical and analytical development, CMC

Together with our clients we participate in planning and suggesting relevant drug formulation- and process development, analytical development, biopharmaceutical evaluations and quality documentation including stability studies.
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Drug development strategies and gap analyses

The goal of a gap analysis is to identify missing pieces in your drug development program. This supports your drug development strategy going forward with specific action items, whichever development phase you are in.

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Abridged applications for generics and hybrids

When the data exclusivity period for a medicinal product expires, it opens up the possibility for other companies to register their products based on the data from the original product. These abridged applications can be submitted through the generic, hybrid or biosimilar regulatory paths.
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What happens at our first meeting? 🤝

A first meeting is a good start. At the initial meeting, experts from SDS Life Science will do an inventory of your project. By mapping what competencies you have in-house and where you are in the process we can quickly identify what competencies you are in need of. 

The first meeting is, of course, free of charge. 

Contact our director of Drug Development

Send an inquiry to Christina Erixon

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