PRODUCT DEVELOPMENT RESOURCES
Before you hire a product development partner.
Use a structured diligence discussion to clarify scope, ownership, compensation, manufacturing responsibilities, research costs and the commercial handoff before work begins.
Ten questions to settle in writing
| Agreement area | Question to resolve |
|---|---|
| Scope and decision rights | Which decisions does the client retain, which can PCG coordinate, and what requires written approval? |
| Deliverables and acceptance | What exact briefs, formulas, specifications, records, reports or handoff materials will be delivered, and how will they be accepted? |
| Formula and work-product rights | Who owns existing materials, new work product, improvements and quantitative formulas, and what transfer access is included? |
| Confidentiality and data handling | What information is confidential, who may receive it, how long duties continue and how sensitive files will be exchanged? |
| Fees and partner compensation | What client fees, retainers, pass-through costs, manufacturer compensation or referral economics apply? |
| Manufacturing roles | Who selects, contracts with, pays and qualifies the CDMO, and who approves specifications, changes, testing and release? |
| Research and substantiation | Who defines the question, executes the work, owns data and reports, interprets results and pays specialist costs? |
| Claims and regulatory review | Who reviews proposed labeling and advertising claims, what evidence is relevant to the finished product, and what remains unresolved? |
| Changes, delays and assumptions | How are revisions, new information, client delays, supplier changes and out-of-scope work documented and priced? |
| Exit and transfer | What happens to active work, samples, records, supplier introductions, licenses and unpaid commitments if the engagement ends? |
Separate coordination from execution
A development partner may coordinate formulation, sourcing, research or manufacturing discussions without becoming the manufacturer, laboratory or study site. Name each party, its deliverables, approval authority and direct commercial relationship. For dietary supplements, FDA materials identify 21 CFR Part 111 as the specific CGMP framework and FDA enforcement materials explain that contracting out operations does not remove a firm’s responsibility for products it places into commerce.
Connect proposed claims to the actual evidence
Record the exact express and implied claims under consideration, the product version to which the evidence applies, the planned reviewer and any evidence gap. The FTC’s Health Products Compliance Guidance explains that objective health claims need adequate substantiation before dissemination and that the required support depends on the claim and surrounding evidence.
How PCG frames the commercial model
PCG scopes client-paid development and portfolio work for companies below $50 million in annual revenue. Eligible engagements above $50 million can be fee-free to the client when PCG is compensated by the selected CDMO under agreed terms. Research is separately scoped at market rates. The applicable fees, partner compensation, pass-through costs, rights and exclusions belong in the signed agreement and statement of work.
Prepared October 1, 2026 from the cited official sources and PCG’s stated engagement model. This business-planning worksheet is not legal, regulatory or scientific advice; product-specific review remains necessary.
Discuss an engagement scope ↗FROM INTEREST TO A CLEAR NEXT STEP
Have a launch
date in mind?
Work back from it. Formulation, testing, packaging and manufacturing each need a place in your plan.
- 01Tell us what you want to build.
- 02Discuss feasibility and priorities.
- 03Agree the scope before work begins.