OTC
Quality systems that hold up under scrutiny.
FDA CFR: 21 CFR Parts 201, 210, 211, and 330, as applicable.
Global: ICH Q7, Q9, and Q10; EU GMP (EudraLex Volume 4); PIC/S; and Health Canada GMP expectations, as applicable.
Qualified consultation booking
Start with a focused conversation about the work ahead.
Use this guided intake to share your immediate quality or regulatory priority, current stage, and intended outcome. We will use that context to prepare a relevant consultation.
Built for the moments that demand more
Aseptic
Contamination control, confidence, and command.
FDA CFR: 21 CFR Parts 210 and 211; 21 CFR Parts 600–680 when biologics apply.
Global: EU GMP Annex 1, PIC/S Annex 1, and ICH Q9/Q10, as applicable to the product and operation.
Medical Device
Designing compliance into every decision.
FDA CFR: QMSR (21 CFR Part 820, effective February 2026), 21 CFR Parts 803, 806, and 807, as applicable.
Global: ISO 13485 and ISO 14971; EU MDR or IVDR; and MDSAP requirements for applicable markets.
Cosmetics (MoCRA)
Modern readiness for a changing market.
FDA CFR: FD&C Act/MoCRA; 21 CFR Parts 700, 701, 710, and 712, plus Parts 73 and 74 when color additives apply.
Global: EU Cosmetics Regulation 1223/2009, ISO 22716, and applicable UK cosmetics requirements.
Foods
Food safety programs made practical and resilient.
FDA CFR: 21 CFR Parts 101 and 117; other FSMA rules, including Parts 112 or 121, when applicable.
Global: Codex HACCP, GFSI-recognized schemes, Canada SFCR, and EU food-hygiene rules including Regulation (EC) 852/2004.
Infant Formula
Heightened care for the highest stakes.
FDA CFR: 21 CFR Parts 106, 107, and 117, plus applicable nutrition and labeling provisions.
Global: Codex infant-formula standards and EU Delegated Regulation (EU) 2016/127, where applicable.
Dietary Supplements
From cGMP strategy to confident execution.
FDA CFR: 21 CFR Parts 111 and 101; 21 CFR Part 117 where food CGMP or preventive-control requirements apply.
Global: EU Food Supplements Directive 2002/46/EC, Codex guidance, and target-market ingredient and claims requirements.
GMPs
Practical systems that make good manufacturing practices stick.
FDA CFR: 21 CFR Parts 210–211 for drugs, 111 for dietary supplements, 117 for foods, and QMSR (21 CFR Part 820) for devices, according to product type.
Global: ICH Q10, PIC/S, relevant ISO standards, and market-specific GMP requirements based on product and destination.
The Tomorrow's Crop way
Not just compliant. Prepared to lead.
Whether your goods are regulated or non-regulated, we help turn complex FDA and regulatory expectations into a clear, achievable path forward.
See the opportunity
Start with a focused clarity call and a practical view of what matters now.
Build the program
Shape quality systems, training, and operational habits around your real-world goals.
Perform with confidence
Move forward with an aligned team, measurable readiness, and momentum that lasts.
Choose your next move
Your next move starts here
Choose the level of support that fits your moment. We’ll help you clarify the path, then build it together.
The stage is set. Your standards lead.
Bring your toughest quality challenge. Leave with a stronger way forward.