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Our Pharma Services

With over 20 years of experience, we assist biotech and big pharma in preclinical drug development through consulting, regulatory documentation, and expert statements.

Apotheker

Our Services

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Toxicological threshold determination

Setting Safety Limits: Expert analysis to determine toxicological thresholds in PDEs, EELs, OELs, ADIs, ERAs, and TDIs.

TOX

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Expert statements

Detailed on-demand toxicological evaluations for informed decisions.

EXP

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eCTD

eCTD formatting & compliance of all modules for streamlined approvals.

CTD

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IB & IMPD

Crafting Investigator's Brochures & Investigational Medicinal Product Dossiers for trial success.

IB

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Target safety assessment

Evaluating potential hazards to set safety targets effectively.

TSA

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Literature searches

Focused literature searches tailored to specific inquiries.

LIT

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Drug-device combination products

Navigating complexities of drug-device combination products.

D×D

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Publication writing

Expert writing for impactful medical publications.

PUB

Consultancy

Ad-hoc & micro consultancy

Delivering agile and targeted pre-clinical drug development ad-hoc and micro consultancy. Leverage the experience of consultants with more than 30 years experience in the industry.

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