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Services Approach

Who we are Mission & values

Team Case studies Contact

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Services

Seven disciplines. One accountable team.

Everything it takes to move a molecule from discovery to market, held by one team that answers for the whole journey. No handoffs. No gaps.

Development to launch (D2L)

CMC & Product Development

End-to-end CMC and formulation expertise, from first-in-human clinical development to commercial supply, for NCEs, 505(b)(2)s and generics.

Discovery to IND

Drug Discovery & NCE Development

Flexible, cost-effective discovery and early development chemistry, from hit finding through the IND data package.

Clinical strategy and oversight

Clinical CRO & Bioequivalence

Clinical and bioequivalence strategy with hands-on CRO oversight, from study design to clinical supply.

Strategy and filings, full lifecycle

Regulatory Affairs

Regulatory strategy and compliant submissions across the US, Canada and EU, from IND to post-approval.

Audit-ready quality systems

Quality & Compliance

GMP quality systems built, assessed and strengthened to withstand regulatory scrutiny across FDA, WHO, EU and PIC/S.

Senior leadership, when and where needed

Strategic Advisory & Fractional Leadership

Senior regulatory, quality and CMC leadership on a fractional basis. Portfolio strategy and M&A due-diligence including site and financial assessments.

Alliance and program delivery

CDMO and Testing & Certification (TIC) Management

Experts in the CDMO and TIC industry: select the right partners, negotiate contracts and drive profitability.

Methods that hold up under review

Analytical Development & Validation

Phase-appropriate analytical method development, validation and transfer, with the stability programs and specifications that carry a dossier through review.

Not sure which discipline your program needs? Start with the problem, and we will map the rest.

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Credence

Pharma

Credible partners for pharmaceutical & life-sciences clients. Evidence-led advisory in CMC, regulatory, quality and strategy for NCEs, generics and branded-generics.

Firm

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Mississauga, Ontario, Canada

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