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Formulation Management

    
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Siegfried  Bringing together our long-standing pharma and chemical heritage, we offer as an integrated partner benefit to our customers with more synergy, expertise and value. Explore more about how our broad range of custom...
Situ Biosciences LLC  Situ Biosciences is an independent microbiological laboratory providing testing and product development for microbial performance of industrial and consumer products.
 
Microbial Consultation Microbial product consultation and testimony.
SL Pharma Labs, Inc  SL Pharma Labs, Inc. provides customized high quality laboratory and clinical manufacture services to pharmaceutical, biotechnology and medical device companies in the areas of product/process development, analytical...
 
FORMULATION DEVELOPMENT Full formulation development services for the development of pre-clinical and clinical formulations for a variety of dosage forms including: parenterals ...
Smithers Pharma Services, LLC  Smithers Pharma Services provides pre-formulation and formulation services, analytical chemistry, and pre-clinical and clinical bioanalytical testing, while offering further drug development support through in-house...
 
Analytical Chemistry Employing state-of-the-art instrumentation in HPLC, GC, and mass spectrometry, Smithers Pharma Services develops analytical chemistry methods from first...
 
Formulation development for biologics Formulation development of biologics serves to increase stability, increase resilience to temperature stress, and therefore increase shelf life. Often,...
 
Smithers Viscient  Smithers Viscient, formerly Smithers Springborn, is a global Contract Research Organization (CRO) providing environmental testing and regulatory services for the crop protection, pharmaceutical, industrial chemical, and...
 
Analytical Chemistry Capabilities Assay test validation and qualification services Method development Method validation Customized analytical testing Metabolite...
 
Environmental testing for crop protection products For the Crop Protection industry, Smithers Viscient offers a variety of services to support regulatory submissions in the United States (Federal...
 
SRI International Biosciences  SRI Biosciences is ideally positioned as your single-source partner to seamlessly integrate basic research, drug discovery, and nonclinical development. We are committed to helping youachieve your goals—from lead identi...
 
Analytical Chemistry SRI has state-of-the-art technology and experienced scientists offering a broad range of analytical method development and validation, and quality control...
 
Bioanalytical Services Our laboratories and scientists are skilled in method development and validation for analysis of drugs and metabolites in biological matrices, using...
 
Surmodics  SurModics Pharmaceuticals is a product-focused leader in drug delivery. This business unit is internationally recognized for its contributions to the drug-delivery field since the pioneering days of controlled release in...
SynCo Bio Partners  SynCo is an award winning licensed GMP contract manufacturing organization based in Amsterdam, The Netherlands. As a truly global player in the biopharmaceutical industry, SynCo works synergistically with large and small...
TetraGenx  TetraGenx was formed in 2000 providing pharmaceutical development and consulting services to the North and Central American markets. As the corporation grew, additional complimentary services and staff members were...
The University of Iowa Pharmaceuticals  The University of Iowa Pharmaceuticals (UIP) is the largest and most experienced university-affiliated FDA-registered pharmaceutical manufacturing facility in the United States. * UIP has been developing...
Therapex  Therapex is recognized for consistently providing quality services in product development, technology transfers and commercial manufacturing of non-sterile liquids and semi solids, development services and in-house...
 
Development Services Our in-house services include formulation, test method development and validation, process scale up, process validation and ICH stability. Our formulation...
Therapure Biopharma  Therapure Biopharma is a Contract Development and Manufacturing Organization (CDMO) that specializes in the development, scale up and manufacture of complex biologics. Therapure operates a modern 130,000 ft2 cGMP facility...
 
Biomanufacturing Services Process development and expertise includes: Molecular biology Cell banking Development & optimization of: Upstream cell culture ...
Thomson Reuters  Thomson Reuters Corporation provides intelligent information for businesses and professionals in the financial, legal, tax and accounting, healthcare, science, and media markets worldwide. The company operates in two...
 
Thomson Reuters NeoFax Thomson Reuters NeoFax is designed to help clinicians accurately prescribe, calculate, formulate, and administer essential drugs and parenteral nutrition...
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Formulation Management Research Library

Accelerated Formulation Development Meets NDA Submission Goal
AAIPharma Services Corp.
Accelerated Formulation Development Meets NDA Submission Goal Challenge Requiring a major change in development approach, a pharmaceutical company asked AAIPharma Services to accelerate the timeline of developing an extended release dual active solid oral formulation. An array of excipients were under investigation in order to achieve proper product stability and desired active release profile. ...
 
DAVOSPHARMA Document
DAVOSPHARMA
Case Study #5: CMC Development Team for a Virtual Pharmaceutical Company An emerging pharmaceutical company had just in-licensed an active IND from a large pharmaceutical company. The virtual company had just raised their first tranche of funding and had no one on staff experienced with CMC development issues. DavosPharma was hired as overall project manager with the additional responsibilities ...
 
Using Quality by Design (QbD) for Process Optimization of a Novel Oral Solid Dosage Form
Metrics, Inc
Joe Cobb and his team used the principles of QbD to improve the robustness of a core tablet for a novel modified release oral solid dosage form. View the AAPS 2012 poster and watch a short video about how Metrics applies the principles of QbD to solve formulation development issues.
 
BCS: implications on guidelines and policies for drug products approval world wide
Capsugel
The BCS attempts to identify when dissolution rate is likely to be rate-determining, and to assess when in-vitro/in-vivo correlations would be ex- pected. And that would be, of course, the Class I type of drug, where dissolution is rapid and not the rate-determining step, plasma levels may not reflect product differences, and little or no difference would be expected between oral solutions and ...
 
Your Ideal Pouch/Sachet Partner
Ropack
Pouches/Sachets ensure high-precision dosing and product preservation. Both can be filled under nitrogen and we offer a controlled-humidity environment for pouch filling. Ropack is equipped to package powder, solid, liquid or other single-dosage types. Our pouch/sachet capacity is 540,000 per day. Ropack: Your Ideal Pouch/Sachet Partner. North America Integrity Key Aspects Uniformity of ...
 

Formulation Management Video

AAIPharma Overview AAIPharma Services Corp.
 
IRVINE PHARMA Irvine Pharmaceutical Services
 
Formulation Management Wockhardt Information

Formulation Management News

Formulation Management AAIPharma Services Corp. Pharmaceuticals
Formulation Management Irvine Pharmaceutical Services Pharmaceuticals
Formulation Management Therapex Information
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