A&M STABTEST Labor für Analytik und Stabilitätsprüfung GmbH

PPC Group, a North Asia based full-service CRO founded in 1997, offering a broad range of clinical research services, laboratory and site management services. PPC group has over 23 years’experience in Asia pacific, with headquarters in Shanghai, PPC Group is a subsidiary of Novotech Health Holdings which has over 1550 employees, operating 21 offices across 12 geographies and manage PhaseⅠClinical Pharmacology Units, 4 Bioanalytical Labs (Small Molecule and Large Molecule laboratories) and a Central Laboratory.
Novotech Health Holdings has supported more than 800 customers, performing over 3700 phaseⅠ-Ⅳ clinical trials conducted in over 24 therapeutic areas. PPC Group is the first CRO in Asia who has undergone inspections from all major international regulatory agencies (NMPA, US FDA, EMA, MFDS and PMDA), all resulting in the successful registration of the client’s products. We pride ourselves on understanding the unique set of challenges faced by emerging biopharma companies and are devoted to over-come their challenges and help them maximize their asset value at every stage.

WuXi AppTec provides a broad portfolio of R&D and manufacturing services that enable companies in the pharmaceutical, biotech and medical device industries worldwide to advance discoveries and deliver groundbreaking treatments to patients. As an innovation-driven and customer-focused company, WuXi AppTec helps our partners improve the productivity of advancing healthcare products through cost-effective and efficient solutions. With industry-leading capabilities such as R&D and manufacturing for small molecule drugs, cell and gene therapies, and testing for medical devices, WuXi AppTec’s open-access platform is enabling more than 4,100 collaborators from over 30 countries to improve the health of those in need – and to realize our vision that "every drug can be made and every disease can be treated."

I manage the Drug Product Manufacturing and Discovery Biology for Archer CPS. I serve multiple roles in Archer’s drug discovery, manufacturing and analytical work. My experience ranges from industrial to academic to non-profit environments, working in several fields including Chemistry, Biochemistry, Structural Biology and Drug Formulation. I have developed several immediate and modified release formulations of novel therapeutics and has completed Phase I manufacture of drug product in support of regulatory filings for Archer. I am actively engaged in collaborative efforts with Archer biologists to screen and validate novel drug compounds and targets in addition to overseeing drug formulation, manufacture, and analysis. I have developed many methods for small molecule isolation and characterization for drug discovery, as well as conventional quality control tests required for drug substance and drug product release and stability. I work closely with Archer CPS's Quality Services group in the preparation of the CMC sections for IND and IMPD submissions.

Avrio Biopharmaceuticals is dedicated to providing our clients with high quality, flexible and on time clinical trial material manufacturing services. Our experienced and dedicated staff and our world class facility allow us to provide our clients with timely solutions to meet the demand of early phase clinical trial material manufacturing.

Our newly commissioned, cGMP manufacturing facility offers a full range of services for your clinical trial material production.

Range of cGMP Support Services
Pre-formulation and Formulation Development
Small Molecules
Biopharmaceuticals

Parenteral Fill and Finish Manufacturing
Lyophilization
Blinding and Over-encapsulation
Packaging and Labeling
Regulatory Document Preparation
CMC Support
Clinical Supply Management
Complete Clinical Trial Support
Strategic Clinical Program Management
Clinical Protocol Development
Investigator Recruitment and Qualification
Clinical Study Management, Trial Monitoring and Data Analysis Preparation of Final Regulatory Submissions

PREMIUM PHARMACEUTICAL INGREDIENTS - MANUFACTURED EXCLUSIVELY IN THE USA
BioSpectra is a US Based manufacturer of GMP, pharmaceutical grade ingredients, including Actives, Excipients, GMP Process Chemicals & Bulk GMP Buffers and Solutions. Our focus is small molecule synthesis and true, phase change multi-step purification for both traditional and bio-pharmaceutical applications. Our services include Contract GMP product development coupled with ongoing commercial manufacturing and regulatory support up to and including DMF submissions. All of our manufacturing processes are fully validated. Our US-GMP regulatory package complies with IPEC & ICHQ7 guidelines. Our onsite analytical testing capabilities include multi-compendial and custom specifications with full traceability and transparency of all raw materials and sources.

Our commitment is to quality, compliance and true, US-GMP manufacturing, testing and regulatory support is unparalleled. We own and operate out of 175,000 square feet of FDA registered & inspected GMP manufacturing space, under the most rigorous quality system while holding to the most stringent regulatory demands. Our goal is to be a valued partner in the secure supply chain and the solution to any key ingredient issue our customers may have.

GMP Product Categories:
• Bulk, GMP Biological Buffers
• Active & functional Excipients
• GMP Process Chemicals and Bulk GMP Solution Solutions

Custom GMP Services Include:
• Purification of Key Ingredients
• Full GMP Product Development
• Small Molecule Custom Synthesis
• API Development & Manufacturing
• Custom GMP Compounded Solvents & Solutions

Comprehensive Quality and Regulatory Program
• FDA Registered and Inspected
• Document Support - DMF Submissions
• Global GMP Requirements – US, IPEC, ICH Q7