PHARMACEUTICAL Research & Development

experts with sound experience in the pharmaceutical industry

CONTRACT RESEARCH ORGANISATION (CRO) FOR CLINICAL API DEVELOPMENT AND cGMP COMPLIANT ANALYTICAL SERVICES.

From feasibility studies, process development or optimization up to associated analytical services like analytical method development, validation, transfer and commercial release according to GMP/FDA guidelines with a broad base of state of the art organic/inorganic and elemental analytical methodologies as well as Filing and Post Approval Support.

Experienced scientist consult our customers how to support efficiently based on their demands.

CRO - Pharma

SOME Our Clients

Our services for leading brands like

Custom synthesis and process development – Analytical Services – Consulting

Custom Synthesis

Synthesis and analytical characterization of reference standards, specific impurities or building blocks

Process Development & Optimization

Contract R&D or optimization of lab scale processes by QbD and support of tech transfer to production scale including in-process analytical method development

Analytical Services

Comprehensive range of analytical services in Liquid and Gas Chromatography, Elemental analysis, Polymer analysis, Thermoanalytical methods, Wet Chemistry, Titrations, Spectroscopic and Spectrometric analytical methods from characterizations to commercial release testing

Analytical Method Development and Validation

Development and GxP compliant validation of analytical methods including transfer. Alternatively verification of monography or customer methods for QC release analysis of raw materials, intermediates, active pharmaceutical ingredients (APIs) and drug products

Forced degradation studies

Forced degradation studies also known as Stress Testing of drug substances or drug products according to ICH Q1A and ICH Q1B to predict likely degradation products or degradation pathways and to demonstrate the stability indicating power of analytical methods used

NBCD characterization

Physico-chemical characterization of (nanoparticulated) non-biological complex drugs (NBCD’s), for example to demonstrate equivalence of a generic NBCD to the originator product to ensure similar product efficacy and safety

Pharma Packaging Services

Development and characterization of pharma packagings in terms of failure analysis, forming processes, barrier & shelf life prediction, packaging validation & performance testing and physico-chemical stability analysis of the packaged drug products

Developing

Developing an integrated, big-picture roadmap for your molecule and company.

Suisse TP offers full-service assistance, from mid-preclinical phases to commercialization and beyond. By working with a partner that is just as skilled in the nitty-gritty details and infrastructure of early development as it is with late-phase trials, regulatory requirements, and market access, you can get a customized, strategic roadmap to get you where you want to go.

adapting

Adapting to changes without losing sight of – or progress toward – the end goal.

When the development process hits inevitable bumps in the road, having the right CRO partner makes all the difference. Knowing how to navigate new hurdles, re-envision the development process, and strategically align with regulatory and industry requirements can help your molecule maximize its success premarket so that it’s ready for an impactful launch. A nimble, responsive, experienced CRO can help you avoid major pitfalls and adjust intelligently to any challenge.

planning

Planning and timing each step in the process to maximize ROI and minimize risk.

There’s a lot that goes into drug development. Having a single partner you can rely on – who knows your drug and company strategy inside and out – means each part of your journey is done with care and forethought about the impact on both the present and future of your program. It also results in fewer interruptions and delays, a more predictable development and regulatory review process, tighter budget control, and a more responsive, in-depth relationship with your CRO.