Private-Label Contract Manufacturing

Launch your own branded allograft product line.

Most distributors in Latin America, the Middle East, and Asia-Pacific spend years reselling someone else's brand. VitaLync gives you a different path — your own amniotic membrane patch or DBM product, manufactured to FDA and AATB standards, with complete regulatory documentation for your market.

We handle everything from tissue sourcing through final packaging and export certification. You bring the market relationships and the brand name.

Discuss OEM requirements ✓ Regulatory support included →

FDA

Registered tissue establishment · 21 CFR Part 1271

ISO

ISO 13485 alignment · certification in progress

Licensed

State licenses held where required

End-to-end

From ethical sourcing through export certification — one partner, full chain of custody

End-to-end process

From your brand brief to product in market

Our contract manufacturing service covers every step of the supply chain. You focus on sales, market development, and customer relationships — we handle everything else.

Requirements & NDA

A structured brief covering your target market, product type, volume, regulatory environment, and brand. Confidentiality agreement in place from day one. No obligation at this stage.

Ethical Tissue Sourcing

Tissue sourced from AATB-accredited US partners. Full donor eligibility determination, infectious disease screening, and chain-of-custody maintained from recovery through final product.

Processing & Sterilization

Processed and terminally sterilized to your specification — single or dual-layer amniotic membrane, DBM format, size configuration. Certificate of analysis issued per lot.

Packaging & Labeling

Custom sterile packaging and labeling tailored to your brand specifications and target market requirements.

Export & Regulatory Docs

Regulatory and traceability documentation provided under VitaLync's FDA registration. Country-specific regulatory pathway support available.

OEM product portfolio

Products available for private-label manufacturing

Every product below is available under your brand name with full FDA documentation, AATB-standard sourcing, and regulatory support for your destination market.

Flagship OEM product

Amniotic Membrane Patch

The highest-demand biological wound care product in markets you serve. Derived from placental tissue collected during healthy, full-term deliveries with full informed consent. Recovered from screened, eligible donors and processed under Current Good Tissue Practice (CGTP) in accordance with 21 CFR Part 1271.

Room-temperature storage (4°C–40°C) makes this uniquely viable in markets where cold-chain infrastructure is limited — the core commercial advantage for your distribution territory.

Single-Layer Dual-Layer Pro 2×2 to 10×10 cm Custom sizes Room-temp storage

Clinical indications under your brand

For use as a wound covering — acute and chronic wound surfaces

Wound site covering — sterile protective barrier

Surgical site covering — protective barrier at surgical and soft tissue sites

Surgical and anatomical surface covering — for use as a protective barrier at the application site

Orthopedic OEM

Demineralized Bone Matrix (DBM)

Processed from 100% human allograft bone, with the demineralization process designed to retain native growth factors and proteins that support bone regeneration. Available in multiple formats to meet a range of clinical needs.

Available in multiple formats. Full chain-of-custody documentation and AATB-standard sourcing on every lot.

Putty Paste Strips Chips / Powder Injectable gel Custom formats

Target surgical applications

Spinal fusion — posterior and anterior approaches

Joint reconstruction and revision arthroplasty

Long bone fracture repair and bone defect management

Maxillofacial and dental bone augmentation

Specialty OEM

Soft Tissue Allografts

Tendon, fascia, and other soft tissue allografts for orthopedic reconstruction, offering a safe and reliable solution. Ethically sourced, minimally processed to preserve biological integrity, with full AATB-standard donor screening and chain-of-custody documentation.

Tendon Fascia Custom configuration Research tissue

Applications

ACL/PCL reconstruction and ligament repair

Rotator cuff augmentation and tendon repair

Abdominal wall and hernia repair

Research and anatomical training programs

Regulatory standing

Every product ships with the full documentation package.

VitaLync is an FDA-registered tissue establishment under 21 CFR Part 1271 and holds state licenses where required. Every OEM product ships with the documentation foreign regulatory authorities require — as standard, not on request.

Start the conversation

FDA

Registered tissue establishment · 21 CFR Part 1271

ISO

ISO 13485 alignment · certification in progress

Licensed

State licenses held where required

AATB

All source processors AATB-accredited

Who we work with

Built for partners at every stage

VitaLync's contract manufacturing program serves both established distributors strengthening their market position and new entrants building a biologics portfolio from the ground up.

Regional Medical Distributors

You have the relationships. A private-label product strengthens your position, improves margins, and gives you something no competitor can undercut on price.

Own brand, better margins
Exclusive territory arrangements available
Regulatory pathway support

Ministries of Health

Government procurement programs seeking domestic access to biological wound care products — under a nationally recognized brand, with full documentation for regulatory approval.

National branding and procurement compliance
Volume pricing for government programs
Policy and regulatory framework support

Hospital Networks & Health Systems

Institution-branded wound care product available across all facilities, without dependence on third-party distributors.

Institution-branded product line
Consistent supply across facilities
Staff training and IFU support

Device Companies Expanding into Biologics

Add a biological wound care or bone augmentation product to your portfolio without building manufacturing capability.

Complement existing device portfolio
No manufacturing investment required
Leverage existing surgeon relationships

Why VitaLync for OEM

What separates us from other contract manufacturers

Regulatory depth

We support your import approval — not just the product

Most contract manufacturers hand you a product and leave you to navigate import registration alone. VitaLync's founder spent six years as Director of Accreditation at the AATB and four years advising governments through the IAEA. We have active regulatory relationships in Mexico, Saudi Arabia, UAE, Philippines, South Korea, Jordan, and Uzbekistan. Your import pathway is part of what we bring.

Cold-chain advantage

Room-temperature storage opens markets others can't serve

Amniotic membrane products requiring cryogenic storage are impractical in markets where cold-chain infrastructure is unreliable. Our dehydrated amniotic membrane stores at ambient room temperature (10°C–30°C) — no freezers, no dry ice, no failed deliveries. For a distributor in a secondary city in Mexico or a rural hospital network in the Philippines, this is the difference between a product they can sell and one they can't.

Documentation standard

Every product ships with the full documentation package

VitaLync operates as an FDA-registered tissue establishment under 21 CFR Part 1271. Every OEM product ships with FDA export certificates, donor eligibility records, infectious disease testing results, certificate of analysis, and chain-of-custody documentation — exactly what foreign regulatory authorities require. We prepare this as standard, not on request.

Flexibility

We work with established distributors and new market entrants

We don't require volume minimums that price out smaller or emerging-market distributors. If you have a credible market opportunity and a clear regulatory pathway, we want to talk. Our program is designed to help partners build from a foundation — a modest initial order that proves the market, followed by scaled supply as demand grows.

Common questions

What distributors and health systems ask first

What is the minimum order quantity?

We don't publish a single MOQ because it varies by product type, format, and market. We work with both established distributors placing large initial orders and new entrants building a proof-of-concept supply. Contact us with your target market and anticipated volume and we'll give you a straight answer on whether the numbers work.

How long does it take from agreement to first shipment?

Timeline varies based on product configuration, packaging and labeling requirements, and the destination market's import process. For markets where VitaLync already has an established regulatory pathway, initial shipments can often be arranged more quickly than in new markets. Contact us with your specific product and market requirements and we will give you a realistic timeline based on your situation.

Can we have exclusivity for our territory?

Territorial exclusivity is available and discussed as part of the initial engagement. Terms depend on the market, product type, and committed volume. We're willing to grant meaningful exclusivity to partners who demonstrate genuine commitment to building the market.

Do you handle import registration in our country?

We provide a complete FDA documentation package aligned with the requirements of foreign regulatory authorities, along with optional advisory support to guide the import pathway in emerging markets.