Regulatory Affairs Consulting

What Regulatory Affairs Consulting does

RACON Regulatory Consulting GmbH (operating as Regulatory Affairs Consulting or RACON) is a founder-led, privately-held German regulatory affairs consulting firm headquartered in Schriesheim near Heidelberg, with a regional office in Berlin. Founded in 2012 by Dr. Hans Rensland (initially as RPC Rensland Pharma Consulting, rebranded in September 2015), the firm provides professional services across the full drug and medical device regulatory lifecycle for clients targeting the EU (EMA) and US (FDA) markets. Its core offerings are organized into three pillars: Pre-Approval Support (development consulting, strategic consulting, scientific advice, briefing packages, submission project management), Post-Approval Support (life cycle management, variations, PSUR/PBRER, renewals, sunset clause monitoring), and Interims-Management (temporary RA personnel replacement, complex project support, and RA expert recruitment). Supplementary services include eCTD-Dossier Creation, eSubmission Services across eCTD/NeeS/CESP/PharmNetBund formats, Regulatory Intelligence, Labelling Support, Technical Writing, and Medical Writing, spanning therapeutic categories such as NCE/Generics, Biologics/Biosimilars, ATMP, Phytopharmaceuticals, Homeopathics/Anthroposophics, and Medical Devices. RACON has no proprietary technology platform, no app or API surface, and delivers through a senior expert network supplemented by affiliated partners Achim Schäffler Consulting and Helion Consulting & Services.

The business operates on a professional services, sales-led model with direct consulting engagement to enterprise pharmaceutical and medical device manufacturers plus SMB and start-up clients; pricing is quote-based by project scope and is not publicly disclosed. Reference customers disclosed on the company website and in profile sources include Bayer, Takeda, Berlin Chemie (MENARINI), Merck KGaA, Stada, Ipsen Pharma, Medac, Paul Hartmann AG, Cheplapharm Arzneimittel GmbH, LTS Lohmann Therapie-Systeme AG, R-Pharm, Cytonet, BSN Medical, Horizon, Nycomed, Riemser Arzneimittel, and Dr Theiss Naturwaren. Marketing and demand generation rely on professional association leadership (MEGRA Regional Chairman for Germany, TOPRA, DGRA), industry seminars and conference speaking engagements, and network referrals rather than paid digital channels. The firm is sole GmbH-owned by its founder with no institutional investors, parent company, or disclosed subsidiaries, and operates with 1-10 employees across its two German offices.

Name

Regulatory Affairs Consulting

Legal name

RACON Regulatory Consulting GmbH

Website

https://regulatory-affairs-consulting.com

Company type

Private

Founded year

2012

Operating status

Operating

Headcount range

1–10 employees

Short description

RACON Regulatory Consulting GmbH is a founder-led German boutique regulatory affairs consulting firm serving pharmaceutical and medical device manufacturers with pre-approval, post-approval, eCTD submission, labelling, and interim management services for the EU and US markets.

Ownership category

akta.pro rank

Product category

Pharmaceutical Regulatory Affairs Consulting

NAICS

Other Scientific and Technical Consulting Services (54169), Management Consulting Services (54161)

SIC

Services-Management Consulting Services (8742)

akta.pro primary industry

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

akta.pro secondary industries

Inspection Readiness & Regulatory Authority Support (FDA/EMA/MHRA) (HLAGAKAF), Third-Party/Outsourced Quality & Responsible Person Services (EU QP/RP, US Agent) (HLAGAKAO)

Keywords

• Pharmaceutical regulatory consulting
• Drug approval services
• Medical device compliance
• ECTD submissions
• Regulatory lifecycle management

Headquarters

HQ city

Schriesheim

HQ country

Germany

HQ region

Europe

Offices2 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Marketing or Sales

Revenue model

1. Regulatory Affairs Consulting Services: Professional consulting services for pharmaceutical and medical device regulatory affairs including pre-approval support, post-approval support, interim management, labeling, technical writing, and eCTD dossier preparation.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels2 records

Core offering

RACON is a regulatory affairs consulting firm that supports pharmaceutical and medical device companies across the full product lifecycle — from pre-approval strategy and dossier preparation through post-approval lifecycle management and interim regulatory staffing. Services are delivered for EU (EMA) and US (FDA) markets and span medicinal products (NCE/generics, biologics/biosimilars, ATMP, phytopharmaceuticals, homeopathics) and medical devices. The firm operates as a boutique advisory practice drawing on an affiliated expert network.

Product overview

RACON Regulatory Consulting GmbH is a regulatory affairs consulting firm offering a comprehensive portfolio of services for pharmaceutical and medical device companies. The core offering consists of Pre-Approval Support (development consulting, strategic consulting, scientific advice, briefing packages, submission projects), Post Approval Support (life cycle management, variations, PSUR/PBRER, renewals, sunset clause monitoring), and Interims-Management (temporary staffing, project support, expert recruitment). Additional services include eCTD-dossier creation, eSubmission services (eCTD, NeeS, CESP, PharmNetBund), Regulatory Intelligence, Labelling Support, Technical Writing, and Medical Writing. The company specializes in Medicinal Products (NCE/Generics, Biologics/Biosimilars, ATMP, Phytopharmaceuticals, Homeopathics/Anthroposophics) and Medical Devices regulatory affairs for EU (EMA) and US (FDA) markets. RACON operates through a network of affiliated consultants and serves clients ranging from global pharmaceutical companies to startups.

Differentiator

Problem solved

Functional benefit

Products and services

• Pre-Approval Support

Named customers17 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

Two partnerships are on record, tiered minor.

• Achim Schäffler ConsultingminorStrategic or Co-development PartnerPart of RACON's expert network, providing regulatory affairs consulting synergies for client success.
• Helion Consulting & ServicesminorStrategic or Co-development PartnerPart of RACON's expert network, enabling synergies in pharmaceutical consulting services for client success.

Scale indicators1 record

Recent moves7 records

Expansion highlights5 records

Emerging players

• NSF (Health Sciences): NSF's health sciences division provides regulatory and quality consulting, training, and compliance services to pharma and medical device manufacturers. It is comparable to RACON's regulatory affairs and quality/CMC support offerings, particularly for medical device clients, and operates as a specialized consultancy within a broader standards organization.

Direct peers

• Voisin Consulting Life Sciences (VCLS): VCLS is a European-headquartered regulatory and scientific consulting firm supporting biotech and pharma companies through EMA/FDA strategy, health economics, and clinical development. It directly overlaps with RACON's regulatory strategy, scientific advice, and submission support offerings across EU/US jurisdictions.
• Arriello: Arriello is a European regulatory affairs, pharmacovigilance and quality consultancy supporting pharma and medtech clients across EU/US markets. Its regulatory strategy and lifecycle services place it in direct competition with RACON for mid-sized and enterprise regulatory engagements.
• ProPharma Group: ProPharma Group is a regulatory compliance, pharmacovigilance, and medical affairs consulting firm serving pharma and medical device clients. Its regulatory consulting, medical writing, and lifecycle management services directly mirror RACON's pre-approval, post-approval and labelling support portfolio.
• PharmaLex (now part of Cencora): PharmaLex is a global regulatory affairs and pharmacovigilance consulting firm serving pharma and medical device companies — directly comparable to RACON's pre-approval, post-approval and submission services. Dr. Hans Rensland previously held the role of Head of Submission, Labeling and Operations at PharmaLex, making it the most directly comparable competitor and clearest reference point for RACON's own service model.

Broad incumbents

• Parexel International: Parexel is a global CRO offering regulatory strategy, eCTD submissions, and clinical development services to large pharma. It is comparable to RACON in regulatory capabilities but operates at significantly greater scale and as part of integrated drug development offerings.
• ICON plc: ICON is a global CRO with dedicated regulatory affairs, clinical operations and pharmacovigilance capabilities serving large pharma. It overlaps with RACON's regulatory submissions work but competes as part of a much broader portfolio including clinical and laboratory services.
• Syneos Health: Syneos Health is a global clinical and regulatory services organization with regulatory affairs, medical writing, and pharmacovigilance capabilities. Comparable to RACON at the regulatory delivery layer, though it competes via a fully integrated development and commercialization model.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks5 records

Key highlights6 records

Customer concentration

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

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 Regulatory Affairs Consulting