Product Development

Our experts will work with you to identify your target product profile, developing a program and strategy to realize your goal along the quickest track possible. We excel in risk-assessment and mitigation, and can provide support, guidance, and project management across diverse areas, including preclinical studies, Chemistry Manufacturing Control (CMC), regulatory, bioanalysis, and clinical trial design and execution.

510(K) / 510(K) de novo

adverse event classification

annual safety reports

assay development coordination

bioanalytical program assessment

bioanalytical program development

biostatistics

CCDS

CDISC compliance

clinical & regulatory strategy

clinical trial designs

clinical trial management

data analysis & QC

data management review

data QA

design of IND-enabling studies

development plan

device handling assessment

drug delivery

e-publishing

eCTD publishing

forecasting

formulation

GMP & GCP training

GMP API supply

health economics

human factors evaluation

IND/CTA

investor pitch

KOL advisory

market assessment

medical marketing

medical monitoring

medical writing

meetings with regulatory authorities

method troubleshooting

MoA & target investigation

NDA/BLA dossiers

negotiations with payors

non-clinical document creation

non-clinical document review

packaging

patient advocacy

pharmacology

PMA

post registration trials

preclinical program/study design

preclinical risk analysis

process development

product evaluation

product launch

product life cycle regulatory management

product shelf life recommendations

program planning & management

protocol design

QA/QC

regulatory document creation

regulatory document review

regulatory leadership

regulatory strategy

reimbursement

RMP/REMS

SAE reconciliation, reporting & procedures

safety & DSMB management

sales & marketing

scientific interpretation

setting spec recommendations

study data analysis

target product profile

user requirements testing

vendor management

vendor oversight (CRO/DM/stats)

vigilance advisory

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