Our Services

Here at BioC, our services are designed to help you move your product from the bench to the clinic and finally to the market.

No project is too small
No request is too specific
No request is too comprehensive – we have partnerships developed to deliver across the board

Our goal is to utilize a custom project plan for your specific needs anywhere along the pipeline, from pre-clinical to clinical materials development and distribution.

Service	Description	Preclinical	Clinical	Market
Development	Pre-formulation and formulation Process including lyophilization Analytical method development, qualification, & validation Counterfeit detection
Production	Small batch manufacturing Placebo manufacturing	Oral Topical Sterile	Oral Topical
	Clinical open labeling, packaging, & kitting Blinded & multilingual labeling Label removal & relabeling for expiry & name change	Oral Topical Sterile	Oral Topical Sterile
	Clinical biosample collection kitting & packaging
Testing	Incoming raw material, excipient, & packaging component testing & inspection In-process & release batch testing ICH stability storage & testing Thermal excursion & cycling study per PDA TR 39
Supply Chain	Material procurement to client specifications Receipt, storage, shipping including clinical distribution Sampling, dispensing in ISO 8 cleanrooms Retention sample management Chambers for -80, -25 to -15, 2 to 8, 15 to 25°C Hazardous, toxic, and special security handling Frozen and cold chain management Biorepository
Consulting	Engineering Packaging validation & shipping qualification Supplier quality auditing Supply chain design & management

Service

Description

Preclinical

Clinical

Market

Development

Production

Testing

Supply Chain

Consulting