Sundia Meditech Company, Ltd.

Pre-formulation and Developability Assessment :

1. Solubility, stability, compatibility, logP testing

2. Solid form screening and selection

3. Physicochemical profiling, drug ability assessment

Sundia provides comprehensive service offerings in Chemical Process Research and Development , contain Intermediate and API Synthesis to support GLP toxicology, clinical studies, and commercialization .

Services

1. Route Scouting & Evaluation

2. Process optimization

3. Process Characterization

4. Flow  Chemistry 

5. Sugar Chemistry 

6. Peptide Chemistry (Kilo scale synthesis up to 5-6 amino acid )

Available acute inflammation models

Available chronic inflammation models

Available Metabolic Disorder Models: Non-alcoholic Fatty Liver  Disease (NAFLD)

Available Neuroscience Animal Models:

o L-DOPA-induced dyskinesia ,

o Pain models (hot plate, von Frey hair, tail flick, plantar test) ,

o Learning and memory (Novel object recognition, T maze) ,

o Motor performance and sensory tests (open field, grip strength).

Available Subcutaneous Xenograft Models (more than 70 Models)

Available Syngenic Models (more than 18 Models)

Sundia has 100+ kinase target available. Kinetic selectivity could provide a more informative metric for the therapeutic window.

Sundia utilizes a truly integrated approach to small molecule drug discovery. As an experienced drug discovery service provider, we are able to tailor our strengths and resources to meet our clients’ needs, which range from medicinal chemistry, in vitro / in vivo biology, ADME, DMPK and disease animal models.

With over a decade of experience working with the world’s largest pharmaceutical and biotechnology companies, Sundia has successfully delivered numerous novel, validated drug targets across a range of different therapeutic areas. Sundia’s high quality drug discovery service platform has successfully increased the efficiency of target screening to hit identification to lead optimization.

Sundia provides a broad scope of drug development solutions, ranging from route design, process improvement and optimization, process scale-up, technology transfer from research to commercial scale, and multi-gram to multi-ton manufacturing of Active Pharmaceutical Ingredients (APIs) and intermediates in compliance to cGMP guidelines. Our relentless focus on providing innovative, flexible and cost-effective solutions will enable you to maximize your efficiency and shorten your lead times.

The well trained and experienced DMPK/Bioanalysis scientists in Sundia are divided into three functional groups: in vitro ADME, in-life/PK, LC-MS/MS Bioanalysis and Metabolite ID. Our services in metabolism, transporters, other in vitro studies and pharmacokinetics cover from early discovery to IND-enabling studies. Our clients have achieved submissions of 18 pre-clinical studies to China CFDA or FDA and went through onsite-audits, approvals, registrations; some of the candidates are in clinical studies. We dedicate to high quality and fast turnaround times, competitive prices and strict IP protections.

Sundia’s Analytical research and development (ARD) team offers high-quality analytical services including method development and validation, qualification of reference standards, testing and release studies, stability studies, CMC dossier preparation services. Our team has collaborated with pharmaceutical companies and successfully obtained many U.S.FDA and China FDA IND/ANDA approvals. Sundia is committed to delivering cost effective and high quality analytical services to clients.

Sundia’s Formulation research and development team provides a full range of service modules including pre-formulation research, technical transfer, formulation development, and product registration. Through "One-Stop Shop" formulation and product development platform, our team works seamlessly with the Process Development, Analytical and DMPK teams to help accelerate your drug candidates quickly from the pre-clinical stage to IND/NDA/ANDA filings.

Sundia’s Formulation research and development team provides a full range of service modules including pre-formulation research, technical transfer, formulation development, and product registration.

Services:

1. Formulation screening using stability, dissolution and animal PK

2. Process development based on physicochemical and physical properties of drug candidates

3. Storage and shipping conditions assessment of drug candidates

4. Technology transfer of formulation and manufacturing process to clinical manufacturing sites

5. CMC document preparation for IND/NDA/ANDA submission.

 COVID-19 drug discovery platform

Sundia is helping to stop the virus, We can offer SARS-COV-2 3CLPRO/ MPRO activity inhibition assay for clients.Our system can screen the compounds from nM to uM range to support SAR drug design.