Product Development Strategy
A critical step on the road to regulatory approval and market launch. Pharmaceutical Product Development Strategy begins after the Discovery Phase and proof of concept.
To navigate this phase successfully, you need a multidisciplinary strategic plan that establishes the objectives of your clinical program. It should also align with your requirements and non-clinical/pre-clinical data whilst at the same time ensuring you meet regional regulatory requirements that align with commercial plans.
Contact our specialists to tailor a service plan
Avoid Delays, Reduce Costs
Your pharmaceutical development program should be appropriately powered to allow you draw valid conclusions, but a balance with study size is required to ensure the development costs are controlled. It is also important to take real world evidence and market access into consideration as you work out clinical protocols and synopsis design.
During the course of a drug’s clinical development, continuous review of the incoming trial data is also a key factor in avoiding delays and reducing costs.
We offer global solutions covering the entire product lifecycle
Our solutions, consisting of core services, which are tailored to address each of your unique requirements. Extensive program management expertise is a key success factor within our service solutions.
Smart & Streamlined
Given our expert understanding of the clinical, regulatory and competitive landscape, PharmaLex is perfectly positioned to offer smart strategies and tactics for a pharmaceutical product development across the entire therapeutic spectrum.
Our expert statistical analysis team offers support with the design of streamlined yet powerful statistical analysis plans.
Our comprehensive approach meets the holistic needs of start-ups, venture capital funded firms and small to mid-size biotech companies, while our targeted expertise helps large pharmaceutical companies with specialized development needs.
In keeping with our aim to deliver innovative solutions, we use proprietary software that streamlines wherever possible—including automating redaction, transferring analytical methods between labs or validating bioassays and physico-chemical methods.
Big Data & Beyond
From data science to clinical trial applications, orphan drug designation to statistical services, scientific writing to IMP management, our broad range of services covers every eventuality.
We’re ready to help you:
- Analyze clinical trial data accurately to guide future trial and development decisions
- Optimize study design and clinical protocol with biostatistics
- Improve clinical development programs with randomization, statistical analysis and study powering
- Define TPP to support the target label
- Manage global development programs for tissue, cell and gene therapy products, biosimilars and new biologics, pharmaceutical and orphan drugs
- Implement early phase modeling to schedule development activities at their most effective point
- Support business development with portfolio reviews and asset repositioning
Clinical Development Services
PharmaLex provides global Clinical Development / Clinical Regulatory expertise to support every step of the clinical development pathway, from first in man studies through registration studies as well as post approval programs. This includes software for management of trial master files, resources for day-to-day processing of trial content and associated expert consultancy through one of the PharmaLex family of companies.More Info
Clinical Trial Applications
PharmaLex provides support for all aspects of Clinical Trial Authorisation (CTA) and Investigational New Drug (IND) applications and, with clinical regulations continuing to evolve around the world, it is more important than ever to have the right expertise by your side.More Info
Toxicological Services and Risk Assessment
Be it a drug, medical device, cosmetic, consumer product, or food ingredient, we at PharmaLex have mastered the science of toxicological risk assessment and have helped products sail through rigorous regulatory scrutiny and reach the market.More Info
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