Acceleration Brochure English

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Acceleration Laboratory Services 2634 NE Hagan Rd. • Lee’s Summit, Missouri 64064 816.525.1150 phone • 816.525.1151 fax www.AccelerationKC.com

Transcript of Acceleration Brochure English

Page 1: Acceleration Brochure English

Acceleration Laboratory Services2634 NE Hagan Rd. • Lee’s Summit, Missouri 64064

816.525.1150 phone • 816.525.1151 faxwww.AccelerationKC.com

Page 2: Acceleration Brochure English

At Acceleration Laboratory Services, our first and foremost principle is “people first.” We are founded on that principle and we remain dedicated to the ideal that people matter most. Our associates are both technically astute and customer oriented; they understand that quality is not measured just in the accuracy of results. A true quality product must be timely, accurate, and meet or exceed our customer’s expectations.

Our objective is to make each proposal – every project – a successful venture for both our customers and ourselves.

Associates with Experience and AcumenClients enjoy a higher level of service with Acceleration associates averaging over 10 years experience in the industry. All Acceleration associates are degreed professionals. With an associate turnover rate far lower than most contract research organizations, customers enjoy stability and consistency, which directly affects quality.

Acceleration provides comprehensive, current and customized data and information related to product development, analytical methods, testing and marketing of pharmaceuticals, as well as other types of products. We provide contract testing for a variety of life science businesses, large and small, including virtual companies.

We also provide specialized solutions to address your custom needs.

Acceleration focuses on:

• Analytical Chemistry Services

• Manufacturing Services

• Packaging and Labeling Services

• Storage and Distribution Services

• Customized Solutions

Analytical Chemistry • Analytical Method Development/ Validation/Transfer

• Assay, Related Impurities, Chiral• Forced Degradation Studies• Residual Solvents• HPLC, UPLC, GC, Dissolution, LC/MS, IR, KF,

etc. • Reference Standard Qualification • Method Remediation or Optimization • Development/Validation Report

(appropriate for “Drop-In” to Regulatory Filing)

Release Testing • Drug Substances

• Drug Products (most dosage forms) • Battery of Standard Tests • Compendial testing (USP, EP, & JP) • Excipients (Vendor Qualification Support) • Certificate of Analysis GenerationStability Testing • Drug Substances • Drug Products • ICH (5°C, 25°C/60% RH, 30°C/65% RH,

40°C/75% RH) • ICH Photostability (Options 1 & 2) • Custom Conditions (-20°C, 50°C/75% RH, or per customer needs) • Temperature Cycling Studies • Fully Validated Chambers - Monitored 24/7 • Uninterrupted Power • Protocols • Submission Ready ReportsAdditional Capabilities • Controlled Substances (DEA Schedules I – V) • Potent Compound Handling • GMP Routine Sample Testing • Reference Standard Subdivision and Distribution • Compatibility Studies • Cleaning Validation • GLP Dosing Solution Preparation • GLP Dosing Solution Analysis • GLP Stability Studies • CMC Support • CMC Consulting • Package Integrity

Microbiology Testing • Bacterial Endotoxin USP <85> • Bioburden/Microbial Limits USP

<61> and <62>

Quality Services

• Antimicrobial Effectiveness USP <51> • Sterility USP <71> • Pharmaceutical Water Testing

Manufacturing ServicesGMP Manufacturing Phase I & II Clinical Supplies • Powder in Capsule • Powder in Vial • Aliquotting/Subdividing

Clinical Packaging/Labeling • Primary - Capsules/Tablets in Bottles • Secondary – Packaging, Labeling • Distribution

Storage and Distribution GMP Warehouse – Storage, Inventory, Aliquotting & Global Distribution • Drug Substances • Drug Products (in primary package and kits) • Excipients

Acceleration Gives…Acceleration helps accelerate your drug development through:

Highest Quality • FDA Inspected • GMP/GLP • Intensive Laboratory Training • Intensive SOP Training • Independently Audited

Expedience • We will work with customers to meet deadlines • Special Rush Service

Creative Pricing • Discounts available for volume work • Discounts available for guaranteed work • FTE contracts available

Quality is Paramount. Service is Superior.Acceleration Laboratory Services is an FDA inspected contract drug development and research organization (CRO) headquartered in the Kansas City metropolitan area. Our accomplished associates bring advanced knowledge and attention to detail — along with solid science and an analytical perspective — to achieve quality outcomes at any point during the drug development process.

Acceleration serves clients of all sizes in the pharmaceutical, animal health, other life sciences and food/beverage industries. Acceleration offers analytical services at every phase of the development continuum, including evaluation of chemistry, safety, and stability through packaging, labeling, storage and shipment of product. Our end goal is to make sure the product reaching the consumer is well characterized and as accurately evaluated as possible.