Records Management

PRODUCTS

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    NDA Submissions 505(b)(1) Or 505(b)(2)

    There are clearly defined pathways for drug approval, and choosing the right regulatory pathway for your drug development program requires a thorough understanding of sections 505(b)(1) and 505(b)(2) of the Federal Food, Drug, and Cosmetics (FD&C) Act.

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    Your Top Partner For Ophthalmic Drug Development

    As a leading partner in ocular therapy, Altasciences is at the forefront of ophthalmic drug development. Our integrated CRO/CDMO solutions can support your program from lead candidate selection to market. You will benefit from working with a single partner as your product advances through each phase of drug development—from prototype formulation through preclinical testing, to early phase clinical trials, and manufacturing. This could mean up to 40% in time savings.

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    Leaders In Oral Formulation

    Mikart’s development services include a range of pre-formulation capabilities for both oral solid and non-sterile oral liquid dose drug products.

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    Perceptive eClinical: Clinical Trial Solutions

    Effective RTSM, built on 30 years of experience

    Backed by the industry’s most experienced designers and RTSM specialists, you can rely on Perceptive eClinical to deliver optimized randomization and trial supply management (RTSM) strategies that keep trials on track, even when they don’t go according to plan – and they never go according to plan.

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    Verification For Water Systems

    Do you have unknown service lines in your inventory? Avoid sending communications this fall to residents served by unknown lines and learn how 120Water can help you verify.

WHITE PAPERS AND CASE STUDIES

NEWS