Opus Regulatory

What Opus Regulatory does

Opus Regulatory, LLC is a Boston-headquartered regulatory affairs consulting firm serving pharmaceutical and biotechnology organizations. The company operates through five service pillars: Regulatory Strategy, CMC (Chemistry, Manufacturing, and Controls), Labeling, Advertising & Promotion, and Medical Review & Medical Information. Its workforce is structured as 100+ full-time remote-based consultants with an average tenure of 17 years, the majority at Director level or above, positioning Opus as a senior practitioner pool for project engagements rather than a junior-staffing model.

The firm's revenue model is professional services: client engagements are quoted, project-based, and sold through direct enterprise field sales. Opus complements advisory work with a proprietary educational platform that includes the Global Regulatory Labeling Symposium, the PERI Global Labeling & Regulatory Symposium (co-hosted with PERI), and the Opus Insights webinar series covering topics such as CCN Standards and Target Product Profile/Target Product Label. Public pricing for educational programs spans $79 to $5,985 per ticket. The firm claims a global delivery footprint with explicit USA and Europe coverage, and maintains a partnership ecosystem across the regulatory affairs industry's primary bodies—PERI, RAPS Philadelphia, DIA, and FDLI.

Leadership is concentrated around CEO Sidnee Pinho (30+ years biopharma experience), Interim CHRO Olena Maleckyj (licensed pharmacist, 30+ years HR), VP Finance Scott Pano, and four Practice Leaders (Joel Davis, Kim Raymer, Brandon Stempo, Heta Zaveri) covering the five service pillars. No funding rounds, acquisitions, M&A activity, patents, or AI/ML capabilities are disclosed in the available data. The combination of senior-only staffing, named-practice accountability, and a recurring content/education engine is the most distinctive structural feature of the business.

Name

Opus Regulatory

Legal name

Opus Regulatory, LLC

Website

https://opusregulatory.com

Company type

Private

Founded year

1994

Operating status

Operating

Headcount range

11–50 employees

Short description

Opus Regulatory is a Boston-based regulatory affairs consulting firm with 100+ remote senior consultants serving pharmaceutical and biotechnology companies across five service pillars: Regulatory Strategy, CMC, Labeling, Advertising & Promotion, and Medical Review & Medical Information.

Ownership category

akta.pro rank

Product category

Pharmaceutical Regulatory Affairs Consulting

NAICS

Management, Scientific, and Technical Consulting Services (5416)

akta.pro primary industry

Regulatory Strategy & Global Submissions (IND/CTA/NDA/BLA/MAA) (HLAGAKAA)

akta.pro secondary industries

Regulatory Operations & Publishing (eCTD, RIM, Submission Management) (HLAGAKAC), Regulatory Strategy & IND/NDA/BLA Submissions Support (HLAIALAH)

Keywords

• Regulatory affairs consulting
• Pharmaceutical regulatory services
• Biotechnology regulatory strategy
• Labeling strategy consulting
• Regulatory CMC consulting

Headquarters

HQ city

Cambridge

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Regulatory Affairs Consulting Services: Project-based consulting services providing regulatory strategy, CMC, labeling, advertising/promotion, and medical review expertise to pharmaceutical and biotechnology companies. Services are tailored to client needs across all stages of drug development.

Pricing tiers

Go-to-market motion1 record

Distribution channels2 records

Marketing channels4 records

Core offering

Opus Regulatory is a niche consulting firm that provides regulatory affairs services to pharmaceutical and biotechnology companies across five pillars: Regulatory Strategy, Regulatory CMC, Labeling, Advertising & Promotion, and Medical Review & Medical Information. The firm delivers these services through a remote team of more than 100 full-time consultants, offering fill-the-gaps staffing, functional outsourcing, and project-based regulatory support across all stages of drug development.

Product overview

Opus Regulatory is a niche regulatory affairs consulting firm offering five integrated core service pillars: Regulatory Strategy, Regulatory CMC (Chemistry, Manufacturing, and Controls), Labeling, Advertising & Promotion (Ad Promo), and Medical Review & Medical Information. The firm operates through its Opus Insights education arm, which delivers the Global Regulatory Labeling Symposium (its own annual event) and partners with PERI for the PERI Global Labeling & Regulatory Symposium. Opus Insights also produces webinars including the CCN Standards series and TPP/TPL sessions. The consulting services provide fill-the-gaps staffing, functional outsourcing, and critical needs support for pharmaceutical and biotechnology companies navigating regulatory requirements across the product lifecycle.

Differentiator

Problem solved

Functional benefit

Products and services

• Regulatory Strategy

Quantifiable outcome

• Team satisfaction with consultant expertise and collaborative personalities
• +2 more outcomes

Named customers2 records

Segments3 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Partnerships

Five partnerships are on record, tiered core and minor.

• PERI (Pharmaceutical Education and Research Institute, Inc.)coreStrategic or Co-development Partner · 8 October 2024Continued partnership for the PERI Global Labeling & Regulatory Symposium held in Washington, DC. Opus Regulatory co-developed and presented the comprehensive two-day labeling education program featuring interactive presentations, roundtable discussions, case studies, and collaborative sessions.
• PERI (Pharmaceutical Education and Research Institute, Inc.)coreStrategic or Co-development Partner · 8 October 2023Opus Regulatory developed and presented the PERI Global Labeling & Regulatory Symposium in partnership with PERI. The symposium provides comprehensive labeling education exploring fundamental and specialized concepts including current events and new regulatory initiatives. Faculty includes experts from pharmaceutical companies, thought leaders, academics, and consultant presenters.
• RAPS (Regulatory Affairs Professionals Society) Philadelphia ChapterminorGTM or Marketing PartnerOpus Regulatory sponsors and presents at RAPS Philadelphia Chapter events including networking events and educational sessions on regulatory labeling and ad promo strategy alignment.
• DIA (Drug Information Association)minorGTM or Marketing PartnerOpus Regulatory exhibits at DIA conferences including the Global Annual Meeting, Global Labeling Conference, and Advertising & Promotion Conference. These industry events provide opportunities for networking and brand visibility.
• FDLI (Food and Drug Law Institute)minorGTM or Marketing PartnerOpus Regulatory is a Gold Sponsor of the FDLI Advertising & Promotion for Medical Products Conference, connecting with industry leaders, legal minds, and regulatory professionals on the evolving regulatory landscape.

Scale indicators3 records

Recent moves6 records

Expansion highlights5 records

Direct peers

• ProPharma Group: ProPharma Group is a specialist pharma services firm offering regulatory affairs, compliance, and pharmacovigilance consulting to pharma and biotech sponsors — directly overlapping Opus's regulatory strategy, CMC, and labeling practices.
• Lachman Consultants: Lachman Consultants is a long-standing regulatory CMC and compliance consulting firm serving pharma/biotech — comparable to Opus in CMC, regulatory strategy, and GMP/compliance functional outsourcing to the same client base.
• Halloran Consulting Group: Halloran is a life sciences consulting firm providing regulatory, quality, and clinical development consulting to pharma and biotech sponsors — directly competitive in regulatory affairs and quality/CMC functional outsourcing engagements.
• NSF (formerly NDA Group): NSF's pharma services business (formerly NDA Group / NLP) provides regulatory affairs, CMC, and drug development consulting to pharma clients across the US and Europe — closely comparable in scope, modality, and client type to Opus.
• Biologics Consulting Group: Biologics Consulting Group is a regulatory affairs and product development consulting firm specializing in biologics and complex therapies — closely comparable to Opus's biotech client segment and submission strategy work.

Broad incumbents

• Parexel International: Parexel is a top-3 global CRO with a dedicated regulatory consulting practice covering strategy, submissions, and labeling — competes with Opus for regulatory outsourcing dollars but as part of a much broader clinical-focused platform.
• IQVIA: IQVIA is the largest CRO with embedded regulatory affairs, CMC, labeling, and safety services — a broad incumbent that overlaps Opus's pillars but at significantly greater scale and with technology-enabled tooling.
• ICON plc: ICON is a leading global CRO with a regulatory and drug development services portfolio — competes with Opus in regulatory strategy, submissions, and labeling outsourcing as part of a broad clinical services platform.

Emerging players

• RJM Group: RJM Group is a regulatory and quality consulting firm serving mid-sized pharma and biotech — a smaller, more regional player competing with Opus for functional outsourcing and ad/promo review projects.

Others

• DIA (Drug Information Association): DIA is the leading industry association for regulatory and clinical professionals — not a competitor but an ecosystem partner whose Global Labeling and Ad/Promo conferences Opus sponsors to drive brand and lead generation.

Market position

Strengths5 records

Weaknesses4 records

Competitive moat3 records

Key risks5 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/opus-regulatory

Revenue estimate

Valuation estimate

Number of profiles

Profiles8 records

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 Opus Regulatory