Services

Our Services

Your biopharmaceutical partner in CMC, Regulatory and Quality

CMC

Technical expertise in process development, Process validation, deviation investigations and reports, manufacturing, analytical development, in-process testing/control strategy, quality control, technology transfers, comparability assessments and reports.

Technical/Regulatory Writing

Regulatory support in drafting/reviewing briefing books to support INTERACT and Pre-IND meetings and IND, IND amendments and BLA submissions. Technical writing support for development reports, SOPs, validation protocols and reports, BPRs, investigation reports, manuscripts and white papers.

Regulatory

Non-clinical and CMC regulatory strategy and writing support for FDA, EMA and Health Canada interactions.

Quality

Strategize, set up and operationalize QMS for early phase companies, perform audits, remediation support, draft policies and procedures, and risk assessments.

Vendor Management

Support CDMO/CTO/CRO assessment and selection through RFP process, technology transfers and project management and interactions.

Market Research/Due Diligence

Assess technology, platform and/or companies against current competitive landscape and for individualized customer needs.

Supply Chain/Procurement

Perform supply chain risk assessment to evaluate risk due to single sourcing, supply chain back order, shipping/import/logistical challenges and provide optionality for alternate procurement strategies.

Our Services

Your biopharmaceutical partner in CMC, Regulatory and Quality

CMC

Direct CMC experience from Big Pharma and start-up biotech environments with cross-functional expertise in quality, regulatory, manufacturing, analytics, quality control and stability and a deep appreciation for the interplay among the various functions

Analytical Life Cycle Management

Conceptualize, develop and validate release tests and in-process QC tests for vaccines, viral vector therapies and in vitro devices.

Molecular Biology

Deep expertise in molecular technologies in support of vaccines, therapeutics and devices. qPCR, gel based techniques, arrays, cloning, nucleic acid and protein extractions

High-Throughput Sequencing

Next-generation sequencing and its use in GMP environments to support genome sequencing and variant analysis, adventitious agent detection, and mutanome mapping

Immunology

Antibody isolation and purification, ELISA, ELISPOT, Western blotting, immunofluorescence assays, multi-pronged serology assays

Bioanalytics

Design, develop and validate assays in biological matrices to support
pre-clinical toxicokinetic or biomarker concentration studies, with supporting
dose-formulation verification and stability studies

Sterility/Bioburden Testing

Rapid microbial methods (RMMs), direct inoculation/membrane
filtration tests, B/F Testing, bioburden for medical devices, pharmaceuticals and raw material

Biostatistics

Statistical analysis to justify setting product release specifications
and stability excursion limits

Program Management

Program management of complex biological programs and medical devices from proof-of-concept to commercialization.
Third-party vendor management for outsourced work

Technical/Scientific Writing

• Development reports, SOPs, validation protocols and reports
• Batch production records and work instructions
•Overarching quality management documents
•Regulatory writing (IND, CTA) and FDA responses
• Investigation reports
•Manuscripts and white papers