- VARIPHARM · A VARITEC SERVICE
VariPharm: US regulatory and quality services
Your external
regulatory and quality arm.
For pharmaceutical companies bringing FDA-regulated products to the US market that need regulatory and quality capability but do not have it in-house yet. We take on MAH and labeler responsibilities, manage your regulatory programs, build and maintain your quality system, and oversee your CDMO relationships.
- US market · FDA-regulated products
- MAH and labeler support
- Quality systems
- CDMO oversight
How VariPharm fits your organisation
- ILLUSTRATIVE
Your company
Products, portfolio and commercial decisions
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VariPharm
Your external regulatory and quality function
MAH and labeler
Manufacturing partners
Regulatory programs
Planned and managed
Quality system
Built and maintained
CDMO oversight
Quality governed
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CDMOs
Manufacturing partners
FDA and partners
US regulator and trading partners
One accountable partner for regulatory and quality in the US market.
- What we do
Four responsibilities. One accountable partner.
VariPharm covers the regulatory and quality work that a pharmaceutical company must own, so your team can focus on products and growth.
MAH and labeler responsibilities
We help you take on and carry out the responsibilities of a marketing authorisation holder and labeler.
- Clear ownership of obligations
- Records and commitments maintained
- Support from first product onwards
Regulatory program management
We plan, manage and track your regulatory programs, so nothing is missed.
- Plans and timelines
- Commitments and changes tracked
- Coordination with your partners
Quality systems and documentation
We build and maintain the quality management system your products need.
- Procedures and controlled documents
- Records kept current
- Ready for review and inspection
CDMO oversight
We oversee your CDMO relationships for quality, compliance and performance.
- Quality governance of partners
- Performance and issue follow-up
- One point of accountability
- What we build
When you need the capability before you have the team.
VariPharm is built for pharmaceutical companies that must meet regulatory and quality obligations, but do not yet have that function in-house.
- 1
Bringing products to the US market
You need MAH and labeler responsibilities covered from day one.
- 2
Manufacturing through CDMOs
You rely on manufacturing partners and need active quality oversight of them.
- 3
Building a quality system
Procedures and documentation must be put in place and kept current.
- 4
Growing faster than your team
Your portfolio and partners are expanding, and regulatory work is growing with them.
- How we work
From first conversation to an ongoing function.
- 1
Understand
We review your products, partners, obligations and current regulatory and quality position.
- 2
Set up
We agree responsibilities, put the quality system and processes in place, and align with your CDMOs.
- 3
Run
We operate as your regulatory and quality arm, with clear reporting to your leadership.
- 4
Scale
We extend scope as your portfolio, partners and markets grow.
- Engagement models
Flexible engagement that scales with your needs.
The same flexible approach VariTec brings to supply chain technology, applied to regulatory and quality.
- Defined scope
Start with what you need now
Engage us for a specific responsibility, program or quality need, with a clear scope and timeline.
- Ongoing service
Your regulatory and quality function
We act as your external regulatory and quality arm on a continuing basis.
- Scale
Grow without rebuilding
Add scope as you grow, without the cost and time of building a full in-house team.
- VariPharm and VariTec
Regulatory, quality and supply chain technology from one partner.
VariPharm covers regulatory and quality. VariTec implements and manages the serialization, ERP / WMS and EDI applications behind your products, with business intelligence using vSMAART and AI.
- Outcomes
Regulatory and quality you can rely on.
Clear ownership of your US obligations, without building a full team.
- Compliance
Obligations covered
MAH and labeler responsibilities owned and carried out, with records kept current.
- Quality
Inspection-ready quality system
Procedures, documents and records ready for FDA review.
- Partners
CDMOs under control
Manufacturing partners governed for quality, compliance and performance.