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Pre-Clinical & Early Phase Clinical Development Solutions in the Heart of BioBeach

CMC & Product Development

From R&D through clinical trials to post-market commercialization, Chemistry, Manufacturing, and Controls (CMC) and product development are integral to every stage of a drug’s lifecycle. These functions ensure that products are consistently manufactured to the highest quality standards and comply with regulatory requirements. 

 

Our consultants bring deep expertise in process development, analytical method validation, quality assurance, and more. Their careers provide them with the knowledge to provide expert guidance in optimizing upstream and downstream activities, ensuring your products' quality, safety, and efficacy. Whether you need assistance with scale-up, technology transfer, reviewing toxicology studies and master batch records, or overseeing CMOs/CDMO, our professionals can ensure your products meet rigorous quality standards and regulatory expectations.

CMC 

API Synthesis 

Safety studies 

Drug Formulation Development

Stability studies 

Bioavailability studies 

Quality studies 

 

Analytical Development & Validation 

Optimization 

Quality Contol (QC)

Quality Assurance (QA)

Supply Chain Management 

Technology Transfer

Risk Management 

CDMO Selection & Oversight

Lifecycle Management

Pre-Clinical 

Toxicology 

Acute toxicity studies 

Subchronic & Chronic toxicology studies 

Genotoxicity studies 

Reproductive & Development tox studies 

Safety pharmacology studies 

Pharmacovigilance (PV)

Drug Metabolism & Pharmacokinetics (DMPK) 

Metabolism studies 

Pharmacokinetic studies 

Absorption, distribution, metabolism, and excretion (ADME)

Drug-Drug Interaction (DDI) studies 

First in Human 

Early Product Development 

CRO Selection & Oversight

Clinical 

Patient Inclusion & Exclusion Criteria 

Patient Recruitment 

Monitoring 

Clinical Supply 

CDM & Biostatistics

Related Topics

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Regulatory Affairs

CRO/Vendor Selection & Oversight

Quality Control & Quality Assurance

Clinical Operations

Biometrics

Clinical IT

Medical Affairs

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