Research and Development
We provide global Research and Development expertise to support every step of the clinical development pathway, from first in man studies through registration studies as well as post approval programs.
Our aim is to help our clients strategically navigate through the various phases of research and development to ensure the client creates a robust, innovative strategy to maximize asset value and the probability of success.
Contact our specialists to tailor a service plan
Clarify, Streamline, Repeat
From development CMC to due diligence, project management to program design, regulatory reporting to medical writing, market access to pricing and reimbursement – our wide range of services deliver competitive advantages.
We’re ready to help you:
- Identify which therapies have the most potential—medically and commercially
- Strategize the best global pathway for your product to ensure market access and commercial success
- Understand your market and the pricing it will bear
- Build a scientific case for efficacy and safety—with critical prep work for clinical trials
- Protect your intellectual property locally and around the world
- Gather commercial data for future licensing and partnership deals
- Navigate the necessary regulations, their complexities and unknowns
- Establish close working relationships with health authorities from Day 1
- Manage your development program from start to finish
Our 360° Approach
At PharmaLex, we take a unique, integrated approach to this vital part of development.
Our 1000+ specialists use their multidisciplinary experience to inform the Discovery and pre-clinical phases with tailormade expertise from a multitude of perspectives.
With such a comprehensive level of service—expect fewer headaches, lower development cost and a higher probability of commercial excellence.
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.
Research and Development Services
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
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 strategies needed.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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PharmaLex has 60+ offices in 32 countries serving more than 1600 satisfied clients worldwide. Search your nearest office.