Genedrift

What Genedrift does

Genedrift is a privately held, Boston-domiciled (LLC, Massachusetts) regulatory and pharmacovigilance consulting firm serving life science manufacturers across drugs, medical devices, cosmetics, and food supplements. It operates through local legal entities and licenses in 16+ countries spanning the Americas, APAC, CIS, the UK, and Africa, allowing it to file as a local applicant, hold a marketing authorization, or serve as an FDA agent on a client's behalf and removing the need for clients to establish in-country subsidiaries.

The product surface is organized around two core lines. Regulatory Affairs covers pre-submission consultation, classification applications, due diligence and gap analyses, dossier preparation in CTD, ACTD, and regional formats, MA filing and holding, lifecycle management, and label/artwork management. Pharmacovigilance covers case intake and processing, individual case safety reports, PSUR/PBRER aggregate reports, QPPV services, pharmacovigilance system master file maintenance, literature review, and REMS/RMP support. Technology is positioned as enabling infrastructure rather than a software platform: internal applications and customized tools that integrate with client business systems, ISO 27001 / SOC 1 Type II / SOC 2 Type II / GDPR-compliant data centers, and workflows through country-specific authority portals. There is no developer API, mobile app, or disclosed AI/ML model.

Commercial mechanics are professional services with managed-service undertones: project-based consulting for initial filings and lifecycle changes, combined with retainer arrangements tied to ongoing MA holding, pharmacovigilance operation, and label management. Pricing is quote-based and not publicly disclosed. Delivery leverages an offshore-augmented network that the firm cites as producing up to 40% cost savings for clients versus in-house operations. Go-to-market is consultative, sales-led enterprise engagement targeting life science executives and regulatory functions, supported by a multi-country website with case studies, regulatory resource libraries, and market-insight content. Customers named in case studies include EU-origin drug manufacturers, an Indian conglomerate, a global multi-site manufacturer, a Top 15 global manufacturer (biosimilars), and an Indian firm managing labels for 5,000+ SKUs across 27 countries.

Name

Genedrift

Legal name

Genedrift LLC

Website

https://genedrift.com

Company type

Private

Operating status

Operating

Headcount range

11–50 employees

Short description

Genedrift is a Boston-based regulatory and pharmacovigilance consulting firm that files, holds, and manages marketing authorizations for pharmaceutical, medical device, cosmetics, and food supplement clients across 16+ countries in the Americas, APAC, CIS, the UK, and Africa.

Ownership category

akta.pro rank

Product category

Life Sciences Regulatory Affairs Consulting

NAICS

Research and Development in Biotechnology (except Nanobiotechnology) (541714), Scientific Research and Development Services (5417), Professional, Scientific, and Technical Services (541)

SIC

Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Pharmacovigilance Quality & Compliance (PV audits, QPPV support, PSMF) (HLAGAKAH)

Keywords

• Regulatory affairs consulting
• Pharmacovigilance services
• Drug registration services
• Marketing authorization holding
• Life sciences compliance

Headquarters

HQ city

Boston

HQ country

United States

HQ region

North America

Offices16 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Technology or R&D, Infrastructure, Marketing or Sales

Revenue model

1. Regulatory Affairs Consulting Services: Genedrift earns revenue by providing regulatory consulting and outsourcing services to life science companies. Services include dossier preparation, regulatory filing, MA holding, lifecycle management, pharmacovigilance, and strategic regulatory consulting. The model is primarily project-based and retainer-based consulting, with ongoing managed services for clients requiring continuous regulatory support.
2. MA Holder / Registration Services: Genedrift acts as local MA holder or FDA agent for clients, holding marketing authorizations on their license while clients maintain commercial agreements. Revenue is generated through ongoing retainer arrangements for maintaining and managing registrations, renewals, and variations.
3. Pharmacovigilance Outsourcing: Provides pharmacovigilance services ranging from discrete augmenting of existing operations to fully managed end-to-end PV services. Services include PV system master files, individual case safety reports, aggregate reports, QPPV, literature review. Pricing leverages offshore delivery network for competitive rates.

Go-to-market motion2 records

Distribution channels1 record

Marketing channels7 records

Core offering

Genedrift provides end-to-end regulatory affairs and pharmacovigilance consulting services for the life sciences industry, covering drugs, medical devices, cosmetics, and food supplements across APAC, CIS, EU, and North America. Through owned local legal entities in 16+ countries, it acts as a local regulatory applicant or FDA agent, delivering dossier preparation, marketing authorization (MA) filing and holding, lifecycle management, QPPV, and drug safety monitoring on a customized, project- and retainer-based engagement model. Its offshore delivery network and proprietary pharmacovigilance tooling underpin stated metrics of 100% on-time delivery, >99% quality, and upwards of 40% cost savings versus in-house operations.

Product overview

Genedrift is a regulatory consulting and solutions provider offering a comprehensive suite of services for the Life Science industry, focusing on Regulatory Affairs and Pharmacovigilance. The portfolio consists of two core service lines: (1) Pharmacovigilance Services covering drug safety from case intake through submission, including QPPV, PSUR/PBRER, and literature review; and (2) Regulatory Affairs Services encompassing dossier preparation, MA filing/holding, and product life cycle management. Supporting these are specialized sub-products including Pre-Submission Consultation, Classification Applications, Due Diligence & Gap Analysis, Dossier Preparation, MA/Registration Filing, MA Holding, QPPV and Pharmacovigilance services, Life Cycle Management, and Label & Artwork Management. The company operates across APAC, CIS, EU and North America, handling Drugs, Medical Devices, Cosmetics, and Food Supplements. The offering follows a services-based model rather than a software platform architecture.

Differentiator

Problem solved

Functional benefit

Products and services

• Pharmacovigilance Services End-to-end drug safety monitoring for pharmaceutical sponsors, covering case intake, case processing and submission, PSUR/PBRER aggregate reports, QPPV coverage, systematic literature review, PV system master file, and REMS/RMP support. Sold to enterprise pharma and biotech companies needing compliant post-marketing safety operations.
• Regulatory Affairs Services End-to-end regulatory consulting for life sciences companies, including regulatory strategy, dossier preparation across CTD/ACTD/regional formats, registration filings, quality management systems, and product life cycle management. Targeted at pharma, medical device, cosmetics, and food supplement manufacturers seeking multi-market approvals.
• MA Holding / Marketing Authorization Holder Services Post-registration MA holding using Genedrift's own local licenses, allowing clients to commercialize in target markets without establishing local subsidiaries. Includes renewal, variation, and ongoing license compliance management.
• Dossier Preparation and Registration Filing Complete dossier preparation tailored to each regulatory authority's specific submission format, followed by filing on behalf of clients as local applicant with IP protection. Targeting life sciences companies seeking registration in APAC, CIS, EU, and North America.
• Pre-Submission Consultation and Classification Application Front-end regulatory advisory services, including obtaining FDA feedback prior to intended premarket submission and seeking regulatory authority responses where the same product is classified differently across jurisdictions, to confirm the correct regulatory pathway.
• Due Diligence and Gap Analysis MA transfer and takeover support with comprehensive due diligence and dossier gap analysis aligned with health authority expectations, used by pharmaceutical companies acquiring or transferring marketing authorizations.
• Life Cycle Management and Label & Artwork Management Post-approval variation handling, MA renewals, and compliance application management, paired with regulatory-compliant label and artwork management across multiple countries. Targets enterprises managing large SKU bases in multiple jurisdictions.
• QPPV and Pharmacovigilance Operations Qualified Person for Pharmacovigilance services, comprising case collection, adverse drug event reporting, maintenance of the Pharmacovigilance System Master File, Individual Case Safety Report processing, aggregate report preparation, and systematic literature review. Sold to pharmaceutical companies needing qualified PV coverage.

Quantifiable outcome

• Saved over two years on strategic filing project for EU company entering Asia Pacific
• +5 more outcomes

Named customers8 records

Segments5 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Scale indicators5 records

Recent moves6 records

Expansion highlights6 records

Broad incumbents

• Parexel International: Large CRO with strong regulatory and pharmacovigilance service offerings across global markets. Overlaps with Genedrift's regulatory and PV consulting but operates at significantly greater scale and geographic depth.
• Labcorp Drug Development (Fortrea): Spun off CRO with global regulatory and PV service offerings. Overlaps with Genedrift in regulatory affairs and pharmacovigilance consulting as part of a larger clinical and commercial services portfolio.
• IQVIA: World's largest CRO offering end-to-end clinical, regulatory, and pharmacovigilance services across all major geographies. Overlaps with Genedrift's PV and regulatory affairs offerings as part of a much broader portfolio serving global pharma.
• ICON plc: Major global CRO with regulatory affairs and pharmacovigilance service lines following its PRA Health Sciences merger. Comparable to Genedrift in PV/regulatory capabilities but serves a much broader and larger client base.

Direct peers

• PrimeVigilance (an Ergomed company): Specialized pharmacovigilance and regulatory services provider offering QPPV, case processing, aggregate reporting, and literature review. Closely aligned with Genedrift's PV service line and pharma/biotech client base.
• PharmaLex (now part of Cencora): Global provider of regulatory affairs, pharmacovigilance, and quality compliance consulting services to the life sciences industry. Directly comparable to Genedrift in service portfolio (regulatory + PV consulting) and target customers (pharma, biotech, medical devices).
• ProPharma Group: Regulatory compliance, pharmacovigilance, and quality consulting firm serving pharmaceutical, medical device, and biotech companies. Highly comparable business model focused on outsourced regulatory and PV services with global multi-jurisdictional capabilities.
• Arriello: European-headquartered regulatory affairs and pharmacovigilance services provider for life sciences companies. Comparable mid-sized niche player with similar service mix (regulatory strategy, MA support, PV) and target customer base.

Emerging players

• Freyr Solutions: Global regulatory affairs and pharmacovigilance services provider with strong APAC delivery capabilities and offshore cost structure. Closely comparable mid-sized peer competing for the same multi-jurisdictional regulatory outsourcing engagements.

Regional players

• Novotech: Asia-Pacific focused CRO with deep regulatory and clinical capabilities across the region. Comparable to Genedrift's APAC-centric regulatory delivery model, though Novotech is more focused on clinical trials than PV/MA services.

Market position

Strengths1 record

Weaknesses1 record

Competitive moat6 records

Key risks6 records

Key highlights7 records

Customer concentration

• Facebookfacebook.com/genedrift
• LinkedInlinkedin.com/company/genedrift

Compliance10 records

Revenue estimate

Valuation estimate

Number of profiles

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Genedrift