

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
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