The specification itself: what goes in, at what dose, in what form, and why.

What it covers

• Active selection with the salt or ester form specified, not just the ingredient name
• Dose set against the evidence for the claim you intend to make, not the lowest defensible amount
• Every pairing checked for synergy and antagonism, including absorption competition
• Contraindications mapped against your intended population and common concomitant medication
• Excipient system chosen for the active it has to carry, not the cheapest available

The constraints that only appear once the formula meets a real production line.

What it covers

• Flow, compressibility and blend uniformity at your intended batch size
• Hygroscopicity and the environmental controls your CMO will need to hold
• Overages calculated to hold label claim through shelf life, not just at release
• Excipient interactions that change disintegration or dissolution
• Where a bilayer, a coating or a separate dose is the only way to keep the formula intact

Whether the formula is legal where you intend to sell it, and what you may say about it.

What it covers

• Screening against permitted ingredient lists and dose ceilings in each target market
• Identifying where a single formula cannot serve every market you want
• Novel or restricted ingredients flagged before they become a filing problem
• The claims your formula and dose can actually support in each jurisdiction
• Label content requirements including warnings that the dose triggers

Finding people who can actually make it, and checking what they send you.

What it covers

• Identifying manufacturers equipped for your dose form at your volume
• Qualifying raw-material vendors on specification, not on price alone
• Reading certificates of analysis for what they omit as much as what they state
• Specifying the identity, assay and contaminant testing your product needs
• Reviewing the technical terms of a manufacturing agreement before you sign it