WAYS Pharmaceutical Services
WAYS Pharmaceutical Services is a privately held regulatory submission management firm founded in 2017 and based in Mohnton, Pennsylvania, specializing in eCTD compilation, validation, and lifecycle management for pharmaceutical, biotechnology, and medical device sponsors filing with the FDA.
- Company typePrivate
- Founded2017
- HeadquartersMohnton, United States
- Headcount11–50
- GTM typeB2B
- OfferingServices
What WAYS Pharmaceutical Services does
WAYS Pharmaceutical Services is a privately held, founder-led regulatory submission management firm headquartered in Mohnton, Pennsylvania, founded in 2017 by CEO Matt Stroschein. The company specializes in eCTD (Electronic Common Technical Document) submission management for the U.S. Food and Drug Administration and other regulatory authorities, providing end-to-end services including eCTD structure setup, sequence planning, document assembly, validation, and lifecycle management for INDs, NDAs, BLAs, medical device submissions, and advertising/promotional filings. Its core technical focus is on submission architecture decisions — granularity, hyperlinking, bookmarking, and XML backbone construction — areas where practitioner judgment directly affects reviewer efficiency and rejection risk.
The firm's service portfolio centers on Submission Management Services, supplemented by eCTD Strategy consulting and eCTD Training for client teams. WAYS generates revenue through professional services fees on a quote-based, project or retainer basis, with no public pricing. It targets three primary segments: early-stage pharmaceutical companies approaching first INDs, biotechnology companies managing complex multi-sequence lifecycle programs, and medical device companies navigating electronic submission formats. Named enterprise customer Sarepta Therapeutics is publicly endorsed as a Submission Management Partner.
Distribution is sales-led and direct, with practitioner engagement rather than account-management handoffs, and a referral partnership with London-based Green Room Life Sciences supporting European market reach. WAYS pursues a content-driven go-to-market strategy — a branded podcast (WAYS OF WORKING), webinars, white papers, and a blog — to build thought leadership and inbound demand. The firm operates without disclosed external funding, has no subsidiaries, and maintains no patents or trademarks in the available record.
WAYS Pharmaceutical Services firmographics
Firmographics- Name
- WAYS Pharmaceutical Services
- Legal name
- WAYS Pharmaceutical Services
- Website
- https://waysps.com
- Company type
- Private
- Founded year
- 2017
- Operating status
- Operating
- Headcount range
- 11–50 employees
- Short description
- WAYS Pharmaceutical Services is a privately held regulatory submission management firm founded in 2017 and based in Mohnton, Pennsylvania, specializing in eCTD compilation, validation, and lifecycle management for pharmaceutical, biotechnology, and medical device sponsors filing with the FDA.
- Ownership category
- akta.pro rank
WAYS Pharmaceutical Services industry classification
Industry- Product category
- Regulatory Operations Services
- NAICS
- Professional, Scientific, and Technical Services (54)
- SIC
- Services-Health Services (8000), Services-Commercial Physical & Biological Research (8731)
- akta.pro primary industry
- Regulatory Operations & Publishing (eCTD, RIM, Submission Management) (HLAGAKAC)
- akta.pro secondary industries
- Regulatory Submissions & Clinical Content Management (eCTD/Publishing) (HLACAOAN), Regulatory Strategy & IND/NDA/BLA Submissions Support (HLAIALAH), Medical Writing & Clinical Documentation FSP (HLAGAOAC)
Keywords
Where WAYS Pharmaceutical Services is headquartered
LocationHeadquarters
- HQ city
- Mohnton
- HQ country
- United States
- HQ region
- North America
Offices1 record
Markets served
WAYS Pharmaceutical Services business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Personnel, Operations, Technology or R&D, Marketing or Sales, Others
Revenue model
- Regulatory Submission Management Services: WAYS generates revenue through professional services fees for regulatory submission management. The company provides end-to-end support for eCTD submissions including structure setup, document compilation, validation, and submission to regulatory authorities. Services are tailored to client needs across INDs, NDAs, BLAs, and lifecycle programs.
Go-to-market motion1 record
Distribution channels2 records
Marketing channels7 records
WAYS Pharmaceutical Services product offering
Product offeringCore offering
WAYS Pharmaceutical Services provides end-to-end regulatory submission management services for life sciences companies, centered on eCTD (Electronic Common Technical Document) compilation, validation, and lifecycle management for FDA and other regulatory authorities. The firm supports sponsors of INDs, NDAs, BLAs, medical device 510(k) submissions, and ongoing compliance maintenance (annual reports, amendments, supplements), with complementary eCTD strategy consulting and training offerings.
Product overview
WAYS Pharmaceutical Services is a regulatory submission management partner offering a portfolio of services centered on eCTD submissions for life sciences companies. The core offering is Submission Management Services, which provides end-to-end eCTD compilation, validation, and lifecycle management. This is complemented by eCTD Training services (educating client teams on eCTD standards) and eCTD Strategy Services (strategic consulting on submission architecture). The company also provides educational content including the WAYS OF WORKING Podcast and white papers on topics such as finding regulatory submission partners and technical rejection criteria.
Differentiator
Problem solved
Functional benefit
Products and services
- Submission Management Services End-to-end regulatory submission management service providing eCTD compilation, validation, publishing, and lifecycle management for INDs, NDAs, BLAs, medical device submissions, and ongoing maintenance activities (annual reports, amendments, supplements) for pharmaceutical, biotechnology, and medical device sponsors.
- eCTD Training Training service that educates client regulatory affairs and product development teams on eCTD standards, submission requirements, and best practices for electronic regulatory submissions.
- eCTD Strategy Services Strategic consulting services helping sponsors with eCTD structure decisions, granularity planning, sequence strategy, and regulatory submission architecture to optimize submission outcomes and reviewer experience.
Quantifiable outcome
- Prevents technical rejections that could result from late engagement or poor submission structure
- +1 more outcomes
Companies that use WAYS Pharmaceutical Services
Customer profileNamed customers1 record
Segments4 records
Ideal customer profiles4 records
WAYS Pharmaceutical Services technology and API
TechnologyTechnology focussed No
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature4 records
WAYS Pharmaceutical Services partnerships and signals
Strategic signalPartnerships
Two partnerships are on record, tiered core.
- TradeCraft Clinical ResearchcoreStrategic partnership formalizing two years of cross-client collaborations where WAYS provided submission management and publishing services while TradeCraft delivered CDISC-compliant data packages. The alliance offers comprehensive solutions for small teams needing data expertise alongside efficient submission management, targeting CDISC and eCTD compliance.
- Green Room Life SciencescoreStrategic partnership with London-based Green Room Life Sciences to establish local EU market presence as WAYS continues European expansion. Green Room serves as business development and referral channel, providing local expertise in assessing client needs and connecting European pharmaceutical, biotech, and medical device companies to WAYS regulatory submission services.
Scale indicators2 records
Recent moves6 records
Expansion highlights5 records
WAYS Pharmaceutical Services competitors and assessment
Company assessmentDirect peers
- ProPharma Group: ProPharma provides regulatory affairs, compliance, and quality consulting services to pharma, biotech, and medical device companies, including submission management support. Closely comparable service portfolio and customer base to WAYS.
- Camargo Pharmaceutical Services: Camargo is a regulatory strategy and consulting firm specializing in 505(b)(2) and complex generic submissions for small and mid-size pharma, with deep expertise in FDA regulatory pathways. Highly comparable to WAYS' regulatory operations and submission support model.
- Pharmalex: Pharmalex provides regulatory affairs and scientific affairs consulting across US and EU, including submission management and lifecycle support. Comparable to WAYS in regulatory operations focus, with broader geographic footprint.
- C3i Solutions (now part of Cencora): C3i Solutions was a dedicated eCTD submission publishing and regulatory operations services provider serving pharma and biotech sponsors, directly comparable to WAYS' core offering of eCTD compilation, validation, and lifecycle management. Acquired by Cencora, it represents the most direct functional peer.
- Halloran Consulting Group: Halloran is a regulatory, quality, and clinical consulting firm serving emerging biotech and pharma sponsors with submission strategy and execution support. Similar scale, customer profile, and service orientation to WAYS.
Broad incumbents
- Parexel International: Parexel is a large global CRO offering regulatory consulting and submission services as part of a broader clinical and biopharmaceutical development portfolio. Represents the broad incumbent against which WAYS competes for regulatory operations work.
- IQVIA: IQVIA is a global life sciences services and analytics firm with regulatory affairs and submission management offerings as part of its integrated CRO platform. A significant broad incumbent in the regulatory operations market.
- ICON plc: ICON is a large global CRO with regulatory services including submission publishing and lifecycle management, often packaged with clinical development. A broad incumbent competing for the same enterprise sponsor budgets as WAYS.
Others
- Veeva Systems: Veeva provides regulatory information management software (Vault RIM) and content management tools that automate eCTD publishing and submission management. Not a direct services competitor, but a technology ecosystem that shapes the addressable market for WAYS' manual services.
Emerging players
- Veristat: Veristat is a mid-size clinical research and regulatory services firm focused on complex therapeutic areas and emerging biotech, with submission and regulatory affairs support. Comparable customer profile and service mix to WAYS, slightly larger.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat4 records
Key risks6 records
Key highlights6 records
Customer concentration
WAYS Pharmaceutical Services social profiles
Digital presenceWAYS Pharmaceutical Services financial estimates
Financial estimateRevenue estimate
Valuation estimate
WAYS Pharmaceutical Services leadership team
Management profileNumber of profiles
Profiles4 records
WAYS Pharmaceutical Services funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
WAYS Pharmaceutical Services M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about WAYS Pharmaceutical Services
What does WAYS Pharmaceutical Services do?
WAYS Pharmaceutical Services provides end-to-end regulatory submission management services for life sciences companies, centered on eCTD (Electronic Common Technical Document) compilation, validation, and lifecycle management for FDA and other regulatory authorities. The firm supports sponsors of INDs, NDAs, BLAs, medical device 510(k) submissions, and ongoing compliance maintenance (annual reports, amendments, supplements), with complementary eCTD strategy consulting and training offerings.
Is WAYS Pharmaceutical Services a public or private company?
WAYS Pharmaceutical Services is a private company. It is classified as founder individual operated bootstrapped and is currently operating.
When was WAYS Pharmaceutical Services founded?
WAYS Pharmaceutical Services was founded in 2017. It employs 11 to 50 people.
Where is WAYS Pharmaceutical Services based?
WAYS Pharmaceutical Services is headquartered in Mohnton, United States, in the North America region.
How does WAYS Pharmaceutical Services make money?
One revenue line is on record: regulatory Submission Management Services.
Who are WAYS Pharmaceutical Services's main competitors?
Direct peers on record are ProPharma Group, Camargo Pharmaceutical Services, Pharmalex, C3i Solutions (now part of Cencora) and Halloran Consulting Group. Broad incumbents are Parexel International, IQVIA and ICON plc. Veeva Systems is listed as an others. Veristat is listed as an emerging player.
Does WAYS Pharmaceutical Services have an API?
No public API is recorded for WAYS Pharmaceutical Services.
What industry is WAYS Pharmaceutical Services in?
WAYS Pharmaceutical Services's product category is Regulatory Operations Services. Its primary akta.pro industry code is HLAGAKAC, Regulatory Operations & Publishing (eCTD, RIM, Submission Management), with a secondary code of HLACAOAN, Regulatory Submissions & Clinical Content Management (eCTD/Publishing). Its NAICS code is 54 and its SIC code is 8000.