Catalent Pharma Solutions

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

Specializing in the development and manufacture of innovative prescription and over-the-counter (OTC) therapies, privately held Fleming Pharmaceuticals is the proud maker of MAGONATE®, NEPHROCAPS®, NEPHROCAPS® QT, ThyroShield®, ProBarimin QT® and the OCEAN® Nasal Care line of products.

Established in 1960, the company has developed products for a variety of clinical conditions in allergy, pediatrics, nephrology, nutrition, and obstetrics/gynecology.

Based in the greater St. Louis area, our fully integrated headquarter facility houses state-of-the-art liquid and solid pharmaceutical manufacturing and packaging, analytical microbiological laboratories, research and development, distribution, marketing, and business administration functions.

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

Access Biologicals LLC is an industry leader in the collection and manufacturing of an extensive portfolio of biological products. Combined with closed-loop material sourcing, we are able to provide critical support for various markets such as in-vitro diagnostic manufacturing, biopharmaceutical, cell culture and diagnostic research & development. Viral testing and donor examinations are performed in accordance with current State, CLIA and FDA regulations allowing us to deliver consistently high quality human blood products. Manufacturing capabilities include a variety of plasma and serum processing in fully auditable facilities with on-site monitored storage. Our high throughput laboratory provides customer-driven responsiveness to specifications and product requirements. Our cell culture division offers a variety of human and animal sera products, and is the only company to directly collect and process Human AB serum at FDA licensed facilities located within the US.



Our headquarters, manufacturing facility and comprehensive donor recruitment office is located in Vista, CA. Sales offices are located in Dartmouth, MA, Atlanta, GA and Philadelphia, PA. Saturn Biomedical, our state-of-the-art plasma and blood collection center in Indianapolis, IN, is uniquely positioned as the largest and newest specialty donor center in the United States.

FDA/CLIA/ISO licenses

FDA Registration # 307234900 – Access Manufacturing
FDA Registration # 3006118943 – Access Biologicals
CLIA Certification ID # 15D0891286 – Access Plasma dba Saturn Bio
FDA License # 1193 – Access Plasma dba Saturn Bio
ISO 9001 Certified

ACG is the world’s only integrated pharma manufacturing solutions company. Capsules + Films & Foils + Engineering + Inspection and Track & Trace systems, we do it all. Your global partners for end-to-end pharmaceutical solutions, no matter where you are.

ACG Worldwide has a presence in over 100 countries with its products and services, employing more than 3,200 members that strive to provide world-class technology across multiple domains. We offer a complete range of solutions beginning with empty capsules; granulation and tablet coating; capsule filling; tabletting; packaging films; blister packing and carton packing to the end-of-line solutions and track and trace systems. With over 20,000 machine installations worldwide, it speaks lengths of the high quality standards we follow at ACG as well as complying with major international quality certifications or legislation's.