Bio Basic Europe | Testing | Clinical studies | Regulatory Affairs

Eurofins Advinus is your trusted partner for specialized discovery, preclinical and early clinical services. Our facility has 30 years of GLP experience in conducting regulatory studies in compliance with global regulations for supporting clinical trials and registration of substances and products globally.

We have over a decade of drug discovery experience for novel, first-in-class targets as well as fast follow on targets and have produced multiple assets that are in preclinical and clinical development. Our discovery services include comprehensive offerings from Medicinal Chemistry, to in vitro Biology, ADMET and Pharmacology.

We offer end-to-end services for a complete IND/IMPD package that includes Safety Assessment/Toxicology and Drug Metabolism and Pharmacokinetic (DMPK) studies along with Chemistry, Manufacturing and Controls (CMC) services.

DMPK services include full spectrum of in vitro screening services, assay development and validation with customized assays and PK studies. We also provide bioanalytical assay development and validation services in accordance with USFDA and EMA guidelines for both Novel Chemical Entities (NCEs), as well as Novel Biological Entities (NBEs) and Biosimilars.

We have successfully submitted enabled 80+ IND packages for submission to regulatory agencies across the world – including USFDA, MHA and EMA. We offer full range of toxicology services to support NDA filing. We have completed 65+ carcinogenicity studies.

Founded in 2004, Pharmaron is a cutting-edge, fully integrated pharmaceutical R&D service platform supporting the life science industry. The company has invested in its people and facilities and established its comprehensive service offerings throughout the pharmaceutical R&D lifecycle. With operations in China, the US and the UK staffed by more than 11,000 employees, Pharmaron has an excellent track record in delivering end-to-end R&D solutions to its partners globally and enabling them to accelerate their novel drug discovery and development process.

Pharmaron is a contract research organization (CRO).

Services:
* Synthetic, medicinal and analytical chemistry services
* Biology services
* DMPK services
* Pharmacology services
* Drug safety assessment services
* Radiochemistry and isotopically labelled metabolism services
* Chemical & pharmaceutical development services
* Clinical development services

www.pharmaron.com

CRO - Contract Research Organization
Library Synthesis
CADD
Bioorganic Chemistry
Discovery Process Chemistry
Radiolabelled Chemical Synthesis
ChemInformatics
in vitro Biology
in vitro Screening
Structural Biology
in vivo Pharmacology
Animal Disease Models
ex vivo Pharmacology
Biomarkers
in vitro ADME
in vivo PK
PKPD
QA
Regulatory Affairs
Discovery Biologics
Process Chemistry
API Manufacturing
Material Science
Formulation Development
Drug Product Manufacturing
Toxicology
Safety Pharmacology
Genetic Toxicology
DART
Pathology
Immunotoxicity
Bioanalytical
14C / Carbon-14 Radiosynthesis
3H / Tritium Radiosynthesis
QWBA
mARG
Clinical AME
Mass Balance
Metabolite Profiling
Microdosing Phase 0
Absolute Bioavailability
DDI
First-in-Human (FIH)
Thorough QT(TQT)
Ethnobridging

BioChroma Analytical Labs LLC is based out of the DFW metroplex in the heart of Texas. It was created to fill the technical gaps in new product development for innovators with new ideas that might not have all the necessary components to make it happen and to offer support for product quality through analytical testing and consulting. We provide an all-encompassing service to help our clients develop a product that is continually manufactured to the level of quality customers expect. Our goal is to provide continual scientific and technical support for entrepreneurs and established businesses based on quality at an affordable price. We are here to provide technical assistance to foster their idea from inception to the marketplace and beyond.
We have experience and expertise in research and development, formulations, scale-up, testing, quality and regulatory of a wide variety of consumer products in the areas of cosmetics, skin care, topical and oral OTCs, food, beverages, dietary supplements, household cleaners and the like.

Product Research and Development: Skin, Body, Hair Care Development, Dietary Supplement Development

Consulting: Packaging Advice, Manufacturing Advice, Plant Inspections, Ingredient Stability Advice, Container Closure Advice, Product Formulation Advice, Quality and Regulatory Advice

Chemistry Analysis: Nutritional Analysis, Mineral Analysis, Vitamin Analysis, Preservative Analysis, Active Ingredient Analysis, Allergen Analysis

Microbiological Analysis: General Microbiology Analysis, Pathogenic Bacteria Analysis, Spoilage Organism Analysis, Preservative Efficacy Analysis, Bacterial Challenge Studies, In vitro Time-Kill Studies, Antibiotic Studies, Water Suitability Testing

Laboratory Research and Development: Transdermal Studies, Antimicrobial Efficacy, Product Specific Studies Aimed at Demonstrating Efficacy or Quality

MedChem Partners is a medicinal chemistry CRO founded in 2006 by Tsvetelina Lazarova and Steven Riesinger. The company is focused on using the extensive experience in early stage company formation and drug discovery to effectively advance small molecule candidates for clients by working closely with the client’s biology and/or chemistry resources. Our experts have extensive experience in moving projects from inception through discovery and into development up to IND enabling toxicology.

At MedChem Partners, we are experts at using synthetic and medicinal chemistry to develop small molecule therapeutics. Unlike large one-stop shops that spread their attention over a variety of tasks, we focus on what we know best. Our expertise is in formulating and implementing a plan to find and optimize small molecules which interact with novel or known biological targets. Whether you already have potential molecules in mind, or have just discovered a novel target, we can develop a plan to find and optimize compounds with therapeutic potential. Since drug discovery is a multidisciplinary endeavor, we have foraged close contacts with a variety of other service providers to augment our expertise in certain areas. Since each company is focused on what it does best, this approach allows us to tap into the best talent in each area. Through out network we have access to in vitro and in vivo testing, in vitro and in vivo pharmacokinetics, computer modeling and in silico prediction, formulation, scale-up and manufacturing, toxicology and regulatory filing, x-ray crystallography, intellectual property and patenting, and consultants in clinical, regulatory, manufacturing, pharmacology, and toxicology.

Accutest, a global independent and internationally accredited Contract Research Organisation (“CRO”), with more than 20 years of experience and over 700+ employees in supporting the end-to-end services for global bio-pharmaceutical, biotech, medical device, nutraceutical and FMCG companies. Accutest is the market leader among independent CROs, with the highest quality standards and quick turnaround times. We have a strong regulatory track record and numerous accreditation/approvals from global regulatory agencies.

We offer services in 3 verticals:
1. Bio-availability and Bio-equivalence studies (BA/BE) -
2. Clinical Development Services (CDS)- Phase II - IV studies, Post marketing, Investigator initiated & stand alone services (medical writing, regulatory consultancy, clinical data management)
3. Biologics Services - Solutions for biosimilars, novel biologics and non-biological complex generics

Successfully cleared below inspections:
USFDA – 33 times (latest Nov, 2018)
WHO – 23 times (latest Jan, 2019)
DCGI- 20 times (latest Oct, 2016)
EMA – 8 times (latest Dec, 2017)