Services

QUALITY AND REGULATORY

HDR COMPANY LLC provides guidance and support for all aspects of CMC related quality and regulatory affairs. Today’s demanding regulatory environment requires solutions that maintain high quality, without draining valuable resources. Our expert consultants can support or supplement your internal quality resources and deliver solutions that accelerate your product development.

GMP Facilities
HDR COMPANY LLC has extensive experience in the design, construction, and validation of cGMP manufacturing facilities. We assist clients in all phases of a facility project, from preliminary technical and economic evaluations through design, construction (including equipment specification, purchase, and installation), start-up, qualification, and final validation. We have relationships with professional engineering firms to facilitate any construction project and can serve as either project manager or owner's representative to ensure that projects remain on schedule and on budget.
 

We are also uniquely positioned to assist companies in determining the best use, value, and potential market for GMP biomanufacturing facilities. Our proprietary manufacturing supply and demandcoupled with our extensive experience in the design and operation of biopharmaceutical facilities allows us to provide realistic and objective assessments of these expensive and time-sensitive assets.
We have worked with multiple clients, ranging from start-up companies to market leaders to:

· Review the technical suitability of biomanufacturing facilities

· Determine regulatory compliance of biomanufacturing facilities and associated systems 

· Assess potential uses and market value of existing facilities and evaluate modifications necessary to address certain market areas

· Market cGMP biopharmaceutical facilities to appropriate target audiences

· Assist in transition planning and management during sale/occupant changeover of a facility 

· Provide conceptual design of facilities to meet business and market objectives 

· Model manufacturing costs and processes to aid decision making.

MANUFACTURING OPERATIONS AND SUPPORT

HDR COMPANY LLC can support manufacturing operations starting from preclinical batches to clinical and conformance batches through commercial batches. 

Clinical Manufacturing
HDR COMPANY LLC has extensive experience in managing and supporting clinical manufacturing operations for both drug substance and drug product. We can serve as the person in the plant by being on-site during a manufacturing run or campaign. We can assist in generation of batch records and sampling plans, perform review of executed batch and testing records, and contribute to investigations and trouble shooting.
Validation
HDR COMPANY LLC has extensive experience in the validation of biopharmaceutical facilities, equipment, and processes. We can prepare Validation Master Plans that are comprehensive and in full compliance with all regulatory requirements (US and foreign). We assist clients in the establishment of documentation standards that are practical and compliant. Using our extensive library of existing documents, protocols, and procedures, we can prepare validation protocols, standard operating procedures, quality test methods, and production batch records suitable for any facility or process. We also provide expert field execution of validation protocols using experienced personnel.
Commercial Manufacturing
Once commercialized the drug development challenges do not end and the business and regulatory risks become amplified. Our expert process understanding and commercial experience can improve process performance or speed investigations or trouble shooting by providing process technical support in the following areas: 

• Cell culture performance issues      
• Contamination and bioburden      investigations and troubleshooting
• Purification robustness      problems 
• Formulation or stability      challenges 
• Filtration and recovery      problems 
• Technology      transfer for additional capacity