Frequently Asked Questions

Pharmaceutical-grade means we apply the same rigorous development and testing processes used for prescription drugs:

• Development at CIS: Our pharmaceutical R&D facility uses drug development protocols
• Advanced delivery systems: Technologies like sublingual, ODT, liposomal, and osmotic release typically used in prescription medications
• Comprehensive testing: Stability studies (accelerated and long-term), dissolution testing, bioavailability optimization following ICH guidelines
• GMP manufacturing: FDA-registered facilities with pharmaceutical quality standards
• Quality specifications: ±5-10% (pharmaceutical standard) vs ±20% (typical supplement standard)

The result: supplements that work better because they’re developed using pharmaceutical science, not just basic formulation.

Supplements: Manufactured in the USA at GMP-certified facilities. Our manufacturing partners include:

• Vox Nutrition Inc.
• Now Foods (Bloomingdale, Illinois)
• Quality Supplement Manufacturing Inc. (Norman, Oklahoma)

Cosmetics: Manufactured at our facility in Bac Ninh, Vietnam and partner facilities.

Development: All products are developed at The Center for Innovation & Science (CIS) in Ukiah, California.

All facilities are GMP-certified and FDA-registered, ensuring pharmaceutical-grade quality standards.

Important clarification: Dietary supplements are NOT FDA approved by design under DSHEA (Dietary Supplement Health and Education Act). This is different from drugs, which require pre-market approval.

However, FDA regulates supplements through:

• cGMP manufacturing requirements (21 CFR Part 111)
• Labeling requirements (21 CFR 101)
• Safety standards (GRAS ingredients)
• Adverse event reporting
• Facility inspections

Novoremedy compliance:

• ✓ Manufactured in FDA-registered facilities
• ✓ GMP-certified per 21 CFR Part 111
• ✓ All ingredients GRAS or approved for supplements
• ✓ Labeling meets FDA requirements

Additional validation: 9 products successfully registered with Vietnam Ministry of Health (requires comprehensive government review and approval), demonstrating exceptional quality that withstands rigorous scrutiny.

This varies by product. Most use vegetable cellulose capsules, but some ingredients are derived from animal sources:

Not Vegan:

• Novo Joint: Contains shellfish-derived glucosamine (from shrimp/crab shells)
• Novo Probiotic: May contain dairy-derived probiotic cultures

Check individual product pages for specific dietary information. We’re working on vegan alternatives for products currently using animal-derived ingredients.

Allergen labeling: All allergens are clearly declared on labels.

Most Novo products can be safely taken together as they address different health needs and don’t have overlapping mega-doses of any ingredients.

We recommend:

• Consult your healthcare provider, especially if you take medications or have medical conditions
• Start with one product at a time to assess tolerance
• Check for ingredient overlap (e.g., if taking multiple products with vitamin C)
• Follow dosing instructions for each product

We can provide a compatibility matrix for common combinations upon request. Contact us at info@novoremedy.com

Advanced delivery systems are pharmaceutical technologies that enhance how active ingredients are absorbed and work in your body:

• Sublingual: Rapid absorption under tongue, bypassing first-pass metabolism (60-70% bioavailability vs 20-40% oral)
• ODT (Oral Disintegrating Tablets): Dissolve in <30 seconds without water, convenient and fast-acting
• Osmotic Controlled-Release: Steady 12-24 hour release, once-daily dosing, no peaks/valleys
• Liposomal: Lipid spheres protect ingredients and enhance absorption 2-4x
• Nanoparticles: Ultra-small particles for better dissolution and absorption
• Transdermal patches: Deliver through skin for sustained release
• Microneedles: Painless micro-delivery for advanced cosmetics

These technologies are typically used in prescription drugs—we bring them to supplements and cosmetics for superior results.

Typical shelf life: 24-36 months from manufacturing date when stored properly.

Expiration date: Clearly marked on every bottle.

Why we’re confident: All products undergo comprehensive stability testing:

• Accelerated stability (40°C/75% RH for 3-6 months)
• Long-term stability (25°C/60% RH for 12-24+ months)
• Testing at multiple time points ensures potency throughout shelf life

Storage guidelines:

• Store in cool, dry place
• Keep away from direct sunlight
• Keep lid tightly closed
• After opening: Use within 6-12 months (specified on label)

We implement multi-stage pharmaceutical-grade quality control:

Stage 1: Raw Material Testing

• Identity verification (HPLC, TLC, FTIR)
• Potency verification
• Heavy metal testing (Pb, Hg, As, Cd)
• Microbial testing
• Pesticide testing (botanicals)
• Only approved materials enter production

Stage 2: In-Process Testing

• Weight checks and blend uniformity
• Environmental monitoring
• Equipment verification

Stage 3: Finished Product Testing

• Potency/assay (±5-10% specification)
• Dissolution testing
• Microbial testing
• Heavy metals (below CA Prop 65 limits)
• Complete COA for every batch

Stage 4: Stability Testing

• Accelerated and long-term programs
• Confirms shelf life and quality throughout product life

Yes, comprehensive heavy metal testing on every batch:

Metals tested:

• Lead (Pb)
• Mercury (Hg)
• Arsenic (As)
• Cadmium (Cd)

Testing method: ICP-MS (most sensitive and accurate)

Standards: We meet California Prop 65 limits (strictest in the USA), which are more stringent than FDA action levels.

Why this matters: Heavy metals are toxic and common contaminants in botanicals and minerals. Our rigorous testing ensures consumer safety.

Yes! Every batch has a Certificate of Analysis (COA) available.

How to request:

1. Find the batch/lot number on your product bottle
2. Email quality@novoremedy.com with the batch number
3. We’ll send the complete COA (typically within 2 business days)

What’s included in COA:

• Batch number and manufacture date
• All test results (potency, purity, microbes, heavy metals)
• Acceptance criteria and pass/fail status
• Testing dates
• Quality Assurance signature

This level of transparency demonstrates our commitment to quality and accountability.

Manufacturing Certifications:

• GMP Certified: All manufacturing partners certified per 21 CFR Part 111 (USA supplements)
• FDA-Registered: All USA facilities registered and subject to inspection
• ISO 22000: Food safety management (herbal extract partners)

Product Certifications:

• Vietnam Ministry of Health: 9 products successfully registered (100% approval rate)
• Halal & Kosher: Select herbal extracts certified

Quality Standards:

• ICH guidelines (pharmaceutical international standards)
• USP methods (United States Pharmacopeia)
• California Prop 65 compliance (strictest heavy metal limits)

Certificates available upon request for business partners and healthcare providers.

Contact us immediately if you experience any adverse reaction:

Contact Information:

• Email: quality@novoremedy.com
• Phone: +1 404 820 4015 (USA) or +84 923 276 879 (Vietnam)

What to provide:

• Product name and batch number
• Description of reaction
• When it occurred
• Your contact information

Our process:

1. Immediate response and assessment
2. Thorough investigation
3. Recommend medical attention if needed
4. Document and report per regulatory requirements
5. Follow up to ensure your wellbeing

Important: If experiencing severe symptoms, seek immediate medical attention first, then notify us.

USA:

• Contact for current distributors: sales@novoremedy.com
• Healthcare providers (integrative/functional medicine practices)
• Select retailers (expanding presence)

Vietnam:

• Hospitals: Major hospital pharmacies nationwide
• Pharmacies: Pharmacity, Medicare, Long Châu, and other chains
• E-commerce: Lazada, Shopee, Tiki, Sendo
• Phone: +84 923 276 879

For bulk/wholesale: Contact sales@novoremedy.com or call +1 404 820 4015

Current shipping:

• USA: Available through distributors and partners
• Vietnam: Nationwide shipping through e-commerce platforms and distributors

International shipping: Available for business/wholesale orders. Contact sales@novoremedy.com to discuss your needs.

Note: International regulations vary. We provide documentation to support import compliance, but buyer is responsible for compliance in their destination country.

Quality guarantee: If any product has a quality defect due to our manufacturing error, we will replace it or refund the purchase price.

Return conditions:

• Products must be in original, unopened condition (unless quality defect)
• Contact us within 30 days of purchase
• Provide proof of purchase and batch number

Cannot be returned:

• Opened products (unless quality issue)
• Products purchased from unauthorized sellers

To initiate return: Contact quality@novoremedy.com with your order details and reason for return.

Yes! We’re actively seeking qualified distribution partners.

Requirements:

• Established business (not startup)
• Relevant industry experience (supplements, health products, or related)
• Business license and good standing
• Financial stability
• Warehouse/storage capability
• Sales force or distribution network

Application process:

1. Submit distributor application online or download PDF
2. We review (1-2 business days)
3. Initial phone/video call to discuss opportunity
4. Due diligence and qualification
5. Agreement negotiation and signing

What we provide:

• Competitive distributor pricing
• Marketing materials and support
• Product training
• Regulatory documentation
• Ongoing support

Apply: distribution@novoremedy.com or call +1 404 820 4015

Yes! Two options available:

1. Private Label (Fast to Market):

• Select from our 9 proven Novo products
• Your brand name and custom label design
• Regulatory documentation included
• Timeline: 6-12 weeks
• MOQ: 1,000 bottles per SKU (supplements), 500 units (cosmetics)

2. Custom Formulation (Unique Products):

• Develop your exclusive formulation
• Pharmaceutical-grade R&D at CIS
• Advanced delivery technologies available
• Timeline: 9-15 months
• You own the formula (IP)

Ideal for:

• E-commerce brands
• Healthcare practitioners
• Influencer product lines
• Retailers seeking exclusivity

Learn more: privatelabel@novoremedy.com or brands@novoremedy.com

Yes! Complete custom formulation development services at The Center for Innovation & Science.

Our capabilities:

• Custom supplement formulation
• Cosmetic product development
• Advanced delivery system integration (sublingual, ODT, liposomal, etc.)
• Pharmaceutical pipeline development (505(b)(2))

Process:

1. Free consultation (30-60 minutes)
2. Feasibility assessment and proposal
3. Development (6-15 months depending on complexity)
4. Testing and validation
5. Tech transfer to manufacturing
6. Launch support

Investment: $50,000 – $500,000+ depending on scope and complexity

Start your project: innovation@novoremedy.com or call +1 404 820 4015

Yes! Complete Vietnam market entry services with proven success.

Our track record: 9 products successfully registered with Vietnam Ministry of Health (100% approval rate)

Services include:

Product Registration:

• Complete dossier preparation
• Testing at certified Vietnamese laboratories
• MOH submission and follow-up
• Approval management

Import & Logistics:

• Import licensing coordination
• Customs clearance
• GSP-compliant warehousing
• Distribution coordination

Distribution Network Access:

• Hospital pharmacy introductions
• Pharmacy chain connections
• E-commerce platform setup
• B2B distributor partnerships

Marketing & Launch Support:

• Vietnamese market strategy
• Localized marketing materials
• Healthcare provider education
• Launch campaign coordination

Investment: $35,000 – $75,000 per product (registration service)
Timeline: 6-9 months average

Contact: marketentry@novoremedy.com or call +84 923 276 879

Minimum Order Quantities vary by product category:

Supplements:

• Standard MOQ: 1,000 bottles per SKU
• Premium products: May be 1,500-2,000 bottles
• First order: Can mix products to meet minimum total

Cosmetics:

• Standard MOQ: 500 units per SKU
• Premium packaging: May be higher

Example: You could order 500 bottles of Product A + 500 bottles of Product B = 1,000 total (meets minimum)

Subsequent orders: Typically 500-1,000 units (lower than initial)

Custom formulation: MOQs vary by product complexity; discussed during project planning

Request detailed quote: privatelabel@novoremedy.com

Novoremedy was founded by Dr. Hiep X. Nguyen, PharmD, Ph.D., DTM with a vision of bringing pharmaceutical-grade innovation to consumer health products.

Dr. Nguyen’s background:

• Decades of pharmaceutical industry experience
• Ph.D. in Pharmaceutical Sciences
• PharmD (Doctor of Pharmacy)
• DTM (Diploma in Tropical Medicine)
• Expertise in drug delivery systems, formulation development, and 505(b)(2) regulatory strategy
• Co-Director, Vietnamese Association of Pharmaceutical Scientists
• Published researcher in pharmaceutical sciences

The founding vision: To elevate supplement and cosmetic industries by applying pharmaceutical science, advanced technologies, and rigorous quality standards.

Mission: “To elevate the supplement and cosmetic industries by applying pharmaceutical science, advanced technologies, and rigorous quality standards—creating products that truly work and brands that healthcare providers trust.”

Vision: “A world where consumers have access to health products developed with the same rigor as prescription medications—where pharmaceutical-grade quality is the norm, not the exception.”

Core Values:

• Scientific Integrity: Evidence drives formulation, not marketing trends
• Relentless Quality: Pharmaceutical standards because consumers deserve consistency
• Innovative Thinking: Challenge industry norms with cutting-edge technologies
• Partnership Approach: We succeed when our partners succeed
• Transparency: Open about processes, testing, and results
• Responsibility: Safety, efficacy, and ethical practices guide everything

USA Operations:

The Center for Innovation & Science (CIS)
2001 Talmage Road
Ukiah, CA 95482, USA
Phone: +1 404 820 4015
Email: hello@novoremedy.com

Functions: R&D, formulation development, quality testing, pharmaceutical pipeline development, client custom formulation projects

Vietnam Operations:

Headquarters:
39A/172 Dai Tu, Dinh Cong
Hanoi, Vietnam
Phone: +84 923 276 879
Email: vietnam@novoremedy.com

Functions: Executive offices, sales, regulatory affairs (MOH liaison), warehousing, distribution

Manufacturing (Cosmetics):
Mao Dien, Thuan Thanh
Bac Ninh Province, Vietnam

Office Hours:

• USA: Monday-Friday, 9 AM – 5 PM PST
• Vietnam: Monday-Friday, 8 AM – 5 PM ICT

We’re a hybrid model that bridges both worlds.

Pharmaceutical heritage:

• Founded by pharmaceutical scientists
• R&D facility operates like a drug development lab
• We use pharmaceutical development processes (QbD, ICH guidelines)
• 505(b)(2) pharmaceutical pipeline (3 products in development)
• Advanced drug delivery technologies

Consumer product focus:

• Products are dietary supplements and cosmetics (not prescription drugs)
• Available over-the-counter
• Focused on wellness, prevention, and daily health support

The difference: We apply pharmaceutical rigor to consumer products, creating supplements and cosmetics that perform like prescription medications but are accessible to everyone.

Tagline: “Think Novo, Trust Remedy” – Innovation you can trust, results you can see.

505(b)(2) is an FDA regulatory pathway for drug development that offers significant advantages:

What it is: A pathway that allows pharmaceutical developers to rely on existing published data (typically safety data for known ingredients) rather than conducting all new studies.

Benefits:

• Faster to market: vs. full NDA (New Drug Application)
• Lower development costs: Don’t need to repeat all preclinical/clinical studies
• Leverage existing data: Use published literature for known ingredients
• Still provides patent opportunities: Novel formulations, delivery systems, combinations
• Requires FDA approval: Full regulatory review for safety and efficacy

Typical uses:

• New formulations of known drugs
• Novel delivery systems (patches, microneedles, etc.)
• New combinations of approved drugs
• New indications for known drugs

Novoremedy’s 505(b)(2) pipeline:

• JAK3/TEC Inhibitor Topical (severe alopecia)
• CGRP Antagonist Transdermal Patch (migraine)
• Peptide Microneedle System

Our team has deep expertise in 505(b)(2) strategy and can assess if it’s right for your product.

Bioavailability is the fraction of an administered dose that reaches systemic circulation and is available to produce an effect.

Why it matters: An ingredient might be effective in studies, but if it’s not absorbed properly, it won’t work in your body.

Common bioavailability issues:

• Poor water solubility (many nutrients don’t dissolve well)
• Degradation in stomach acid
• Poor membrane permeability
• First-pass metabolism (liver breaks down before reaching body)
• Efflux transporters (cells pump substances back out)

How we enhance bioavailability:

• Liposomal delivery: 2-4x enhancement (protects ingredients, enhances absorption)
• Nanoparticles: Increased surface area = faster dissolution
• Sublingual delivery: Bypass first-pass metabolism (60-70% vs 20-40%)
• Permeation enhancers: Help molecules cross membranes
• Bioavailability enhancers: Like piperine (black pepper extract), which can increase absorption 30-200%

Example: Standard curcumin has ~5% bioavailability. Our liposomal formulation achieves 20-40% – that’s 4-8x better results from the same dose.

ICH (International Council for Harmonisation) stability testing is the gold standard for pharmaceutical product stability evaluation.

What it tests: How products maintain quality over time under various storage conditions

ICH stability programs we conduct:

Accelerated Stability:

• Conditions: 40°C / 75% RH (hot and humid)
• Duration: 3-6 months
• Purpose: Predict long-term stability quickly
• Testing points: 0, 1, 2, 3, 6 months

Long-Term Stability:

• Conditions: 25°C / 60% RH (room temperature)
• Duration: 12-24+ months
• Purpose: Confirm shelf life
• Testing points: 0, 3, 6, 9, 12, 18, 24 months

Parameters tested:

• Appearance (color, odor, physical state)
• Active ingredient potency
• Degradation products/impurities
• Dissolution (how fast it releases)
• Microbial (beginning and end)

Why we follow ICH: These are pharmaceutical industry standards—far more rigorous than typical supplement testing. It ensures our products maintain quality throughout their shelf life.

Quality by Design (QbD) is a pharmaceutical approach that designs quality into products from the beginning, rather than just testing for it at the end.

Traditional approach (Quality by Testing):

1. Develop formulation
2. Manufacture
3. Test finished product
4. Hope it meets specifications
5. Reject batches that fail (wasteful)

QbD Approach:

1. Define Target Product Profile: What should the product be?
2. Identify Critical Quality Attributes (CQAs): What characteristics are critical?
3. Understand relationships: How do formulation and process affect CQAs?
4. Design formulation and process: To reliably deliver CQAs
5. Monitor and control: Throughout manufacturing

Result: Consistent, high-quality products with fewer batch failures

QbD Tools we use:

• Risk assessment: Identify what could impact quality
• Design of Experiments (DoE): Systematically study variables
• Design space: Define acceptable ranges
• Control strategy: Implement controls at every stage

Why it matters: QbD is pharmaceutical industry standard—we bring this rigor to supplements and cosmetics for superior consistency and reliability.