Men’s Vitality Tincture
Budget: $30 – $250 USD
I want to shift from sugary majoon-style pastes to a potent, alcohol-free drops formulation that men can dose precisely. The core objective is overall male vitality—erectile support, stamina, and better sperm parameters all in one daily tincture.
Key active botanicals must include standardized extracts of Ginseng, Ashwagandha, and Tribulus Terrestris. I’m open to complementary adaptogens or bio-availability enhancers you can justify through evidence, but those three herbs are non-negotiable and should drive the pharmacodynamics.
PCSIR compliance is my first regulatory milestone, yet the dossier should naturally map onto FDA and DRAP expectations so the formula can travel. That means clean sourcing, documented assays, stability data, and toxicology summaries suitable for a GRAS/NDI-style filing.
Deliverables
• Literature-backed formula with exact extract ratios, solvent system, and targeted marker compounds
• Safety, interaction, and contraindication brief in line with PCSIR monograph requirements
• Bench-scale manufacturing SOP (including filtration, preservation, and bottling) aimed at a hyper-concentrated drop size
• 6-month accelerated and real-time stability plan with acceptance criteria
• Draft submission packet for PCSIR review, cross-referenced to FDA botanical guidance
Please bring proven nutraceutical or herbal pharmaceutics experience so we can move quickly from lab bench to pilot production.
Key active botanicals must include standardized extracts of Ginseng, Ashwagandha, and Tribulus Terrestris. I’m open to complementary adaptogens or bio-availability enhancers you can justify through evidence, but those three herbs are non-negotiable and should drive the pharmacodynamics.
PCSIR compliance is my first regulatory milestone, yet the dossier should naturally map onto FDA and DRAP expectations so the formula can travel. That means clean sourcing, documented assays, stability data, and toxicology summaries suitable for a GRAS/NDI-style filing.
Deliverables
• Literature-backed formula with exact extract ratios, solvent system, and targeted marker compounds
• Safety, interaction, and contraindication brief in line with PCSIR monograph requirements
• Bench-scale manufacturing SOP (including filtration, preservation, and bottling) aimed at a hyper-concentrated drop size
• 6-month accelerated and real-time stability plan with acceptance criteria
• Draft submission packet for PCSIR review, cross-referenced to FDA botanical guidance
Please bring proven nutraceutical or herbal pharmaceutics experience so we can move quickly from lab bench to pilot production.