BioSpectra is a U.S.-based manufacturer of GMP pharmaceutical-grade ingredients, including actives, excipients, GMP process chemicals, and bulk GMP buffers and solutions. Our focus is small molecule synthesis and true, phase-change multi-step purification for both traditional and biopharmaceutical 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 U.S.-GMP regulatory package complies with IPEC & ICHQ7 guidelines. Onsite analytical testing capabilities include multi-compendial and custom specifications, with full traceability and transparency of all raw materials and sources. 

Our commitment to quality, compliance and true, U.S.-GMP manufacturing, testing, and regulatory support is unparalleled. 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 Solutions
             
Custom GMP Services:
     •  Purification of key ingredients
     •  Full GMP product development
     •  Small molecule custom synthesis
     •  API development and manufacturing
     •  Custom GMP compounded solvents and solutions

Comprehensive Quality and Regulatory Program:
     •  FDA registered and inspected
     •  Document support (DMF submissions)
     •  Global GMP requirements (US, IPEC, ICH-Q7)

Biotechnology

Chemicals

Pharmaceutical

BioSpectra, Inc.

BioSpectra, Inc.'s headquarters in Bangor, PA, United States

Richard Mutchler

Greg Fariss

Dora Meissner

Karen Cramer

Crystal Rose Hamelburg

The Quality Assurance and Control team at BioSpectra, Inc. ensures that all pharmaceutical-grade ingredients meet stringent regulatory standards and internal quality benchmarks. They oversee the validation of manufacturing processes, conduct comprehensive analytical testing, and maintain meticulous documentation to support regulatory submissions. By focusing on continuous quality improvement, this team plays a crucial role in upholding the company’s commitment to compliance and excellence in GMP manufacturing.

Quality Assurance and Control

The Laboratory and Compliance Team at BioSpectra, Inc. is responsible for ensuring that all manufacturing processes meet stringent GMP regulations and industry standards. They oversee laboratory testing, validate processes, and manage compliance with global regulatory requirements. The team conducts analytical testing to guarantee product quality and supports documentation for DMF submissions, ensuring transparency and traceability throughout the production of pharmaceutical-grade ingredients.

Laboratory and Compliance Team

The Operations and Technical Support team at BioSpectra, Inc. plays a crucial role in ensuring the efficient and compliant manufacturing of pharmaceutical-grade ingredients. This team is responsible for overseeing the daily operations of production, addressing technical challenges, and maintaining equipment reliability. They also manage validation processes, support process development, and ensure rigorous training for staff to uphold quality standards, ultimately ensuring that all products meet GMP regulations and customer specifications.

Operations and Technical Support

The Operations Team at BioSpectra, Inc. is responsible for ensuring the efficient and compliant production of pharmaceutical-grade ingredients. This team oversees supply chain management, coordinates purchasing, and integrates business processes to maintain high-quality standards in GMP manufacturing. They also prioritize environmental health and safety, while supporting regulatory compliance and customer satisfaction through effective operational strategies.

Operations Team

The Leadership Team at BioSpectra, Inc. is responsible for setting the strategic direction and overarching vision of the company, ensuring alignment with industry standards and regulatory compliance. This team, comprising the President and Founder, Vice President of Process Technology, and Executive Vice President of Quality Systems, drives innovation in GMP manufacturing and product development while fostering a culture of quality and excellence throughout the organization. They play a crucial role in overseeing operations, enhancing customer partnerships, and upholding BioSpectra's commitment to providing high-quality pharmaceutical-grade ingredients.

BioSpectra, Inc.

Org chart

Teams

Quality Assurance and Control

Laboratory and Compliance Team

Operations and Technical Support

Operations Team

Leadership Team

Offices

BioSpectra, Inc.

Org chart

Teams

Quality Assurance and Control

Laboratory and Compliance Team

Operations and Technical Support

Operations Team

Leadership Team

Offices

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