Pharmaceutical & Life-Sciences Advisory
Deep science. Clear strategy. Medicines that reach patients.
Credence experts advise pharma, biotech and life-sciences companies on CMC, regulatory, quality and strategy. Real-world, deep expertise from drug discovery and product development through to approval for NCEs, 505(b)(2)s and generics. Independent, evidence-led and accountable advisory in supporting clients to bring molecules to markets.
20+
Development programs
advised
advised
100+
NCEs, 505(b)(2)s &
generics developed
generics developed
75+ yrs
Combined
leadership
leadership
8+ yrs
Independent advisory
since 2018
since 2018
Unbiased scientific & business solutions.
Clients across
United StatesCanadaEuropean UnionAsia
Who we work with
Emerging biotechGenericsEstablished pharmaCDMOsPrivate equity
01 / Services
Eight 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.
01Development 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.
QbD formulation designHPAPI & high-potent facilitiesScale-up & tech-transfer
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02Discovery to IND
Drug Discovery & NCE Development
Flexible, cost-effective discovery and early development chemistry, from hit finding through the IND data package.
Hit-to-lead & lead optimizationIND data packageFTE chemistry model
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03Clinical strategy and oversight
Clinical CRO & Bioequivalence
Clinical and bioequivalence strategy with hands-on CRO oversight, from study design to clinical supply.
BE study designCRO oversightClinical-supply management
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04Strategy and filings, full lifecycle
Regulatory Affairs
Regulatory strategy and compliant submissions across the US, Canada and EU, from IND to post-approval.
US FDA, Health Canada & EMAIND / CTA / ANDA / NDA / MAAGap assessment & remediation
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05Audit-ready quality systems
Quality & Compliance
GMP quality systems built, assessed and strengthened to withstand regulatory scrutiny across FDA, WHO, EU and PIC/S.
GMP gap analysisSOPs, CAPA & root-causeAudit & inspection readiness
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06Senior 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.
Functional Head of Discovery, R&D, Regulatory & QualityM&A & PE technical diligenceCDMO & TIC business turnaround
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07Alliance 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.
CDMO / CRO selection & contractsPMP-led project managementProgram recovery
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08Methods 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.
ICH Q2 validationMethod transferStability & specifications
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All services
View the full portfolio→
Quality management
Turnkey GMP compliance, delivered audit-ready.
Green-field API and formulation plants or brown-field upgrades: we build the direction, systems and documentation that carry your facility through global audits.
9
Compliance projects
completed
completed
5
Ongoing engagements in
Formulation & API, targeting
FDA, WHO, EU & PIC/S
Formulation & API, targeting
FDA, WHO, EU & PIC/S
8
Consultants with 5 to 20 years
industry experience
industry experience
B.Pharm · MSc · PhD
Consultant credentials in Chemistry & pharmaceutical sciences
Meet the team
→
Private equity & investors
Strategic guidance for private equity.
Technical and regulatory diligence on deal timelines. Data-room review, risk identification, expert reporting, and a regulatory roadmap for day one post-transaction.
15+
PE and M&A due-diligence engagements across business acquisitions, product portfolios and manufacturing site audits.
02 / Approach
Every crossing follows the same discipline.
The bridge is our promise of a safe crossing from one shore to the other, whatever the terrain. Every program crosses three piers.
Where the name comes from→PIER 01
Discovery & design
Discovery and lead-optimization support with phase-appropriate formulation design. Programs set up to succeed from the first batch.
PIER 02
Engineer the span
Scale-up, tech-transfer, validation and clinical bioequivalence. The load-bearing work that makes a formulation manufacturable and approvable.
PIER 03
File & launch
eCTD filings for the US and EU, approval support and launch. Bench to commercial, one continuous crossing.
Program management
Workstreams, stage gates and risk, held on one plan.
PMP-certified leads with real R&D depth run the timeline, the risk register and the partners against it, so a program crosses its stage gates on plan rather than on hope.
CDMO & program management→
03 / Who we are
An independent partnership of scientists, regulators and strategists.
Founded in 2018, Credence Pharma Consulting is an independent advisory firm. We give emerging biotech, generics and established pharma clear, compliant paths from discovery to commercialization. Our advice answers to the science, never to a manufacturing or commercial agenda.
Independence
No manufacturing stake. No partner agenda. Our only interest is getting your product to patients, so the advice you get is the advice you need.
Scientific rigour
Counsel from a team that has developed 100+ NCEs, 505(b)(2)s and generics across oral solids, injectables, nasal and specialised delivery. Operators, not observers.
04 / Case studies
An NCE gastric-retention modified-release tablet for diabetes. Developed and scaled through Phase 1 to 3 CMC, tech-transferred for process-validation batches. Approved and launched in the US in January 2023.
Gastric-retention MR program for diabetes
Boston-based biotech · NCE · Phase 1 to 3 CMC · Approved January 2023
Approval is closer than you think.
Tell us where your program stands: discovery, development, filing or launch. We will map the line that carries it successfully to the next stage-gate towards commercialization.
Credence
Pharma
Credible partners for pharmaceutical & life-sciences clients. Evidence-led advisory in CMC, regulatory, quality and strategy for NCEs, generics and branded-generics.
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