What Spektra Consultoria does

Spektra Soluções Científico-Regulatórias Ltda (doing business as Spektra Consultoria) is a Brazilian scientific and regulatory consultancy founded in late 2018 by Mariah Ultramari and headquartered in São Paulo. The firm delivers technical-scientific evaluations that support chemical safety and regulatory decisions for pharmaceutical and health products, with a portfolio of seven core service areas: non-mutagenic and potentially mutagenic impurity assessment, extractables and leachables (ICH Q3E), impurity formation analysis, nitrosamine risk assessment, health-based exposure limits (LEBS/PDE/OEL), and customized in-company training. Its primary customer segment is enterprise pharmaceutical companies, with named clients including Abbott, AbbVie, Aché, Bayer, Biolab, Catalent, Cipla, Cristália, Daiichi Sankyo, EMS, Eurofarma, Ferring, Galderma, Grünenthal, Libbs, Megalabs, Prati-Donaduzzi, Roche, Sanofi, Takeda, Teuto, and Zoetis.

The firm's technical stack is built on third-party in silico platforms accessed through representation agreements: Derek Nexus, Sarah Nexus, Mirabilis, and Zeneth from Lhasa Limited for mutagenicity, nitrosamine, and degradation prediction; ASAPprime from FreeThink Technologies for accelerated stability prediction; and Fusion QbD from S-Matrix for method and product development. Spektra layers these tools with a proprietary curated LEBS database of 900+ molecules across multiple administration routes, described as the largest in Brazil, which differentiates its PDE/OEL offerings. Go-to-market is sales-led through direct engagement and the website contact form, with thought leadership amplified through a LinkedIn presence, Instagram, a YouTube/Spotify podcast (Pasteur.Laria), and an educational blog.

Commercially, Spektra operates as a professional services firm with project-based consulting revenue and no publicly disclosed pricing. The company has remained privately held with no disclosed funding rounds. In December 2025, Spektra announced it became part of Consult Lhasa, with operations, administrative structure, and service quality stated to remain unchanged. The firm employs approximately 19 people and reports 2000+ reports submitted to regulatory agencies and 1000+ ANVISA-approved projects with zero rejections, alongside a 1st place finish in the Regulatory Consultancy category at the 29th Sindusfarma Quality Award in 2025.

Name

Spektra Consultoria

Legal name

Spektra Soluções Científico-Regulatórios Ltda

Website

https://spektraconsultoria.com.br

Company type

Private

Founded year

2018

Operating status

Operating

Headcount range

11–50 employees

Short description

Spektra Consultoria is a São Paulo-based scientific and regulatory consultancy providing impurity, nitrosamine, and exposure-limit assessments to enterprise pharmaceutical companies in Brazil using in silico toxicology tools.

Ownership category

akta.pro rank

Product category

Pharmaceutical Regulatory Consulting

NAICS

Other Scientific and Technical Consulting Services (54169), Management, Scientific, and Technical Consulting Services (5416)

SIC

Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Toxicology & Safety Assessment CROs (GLP) (HLAGAAAC)

akta.pro secondary industries

Pharmacovigilance, Risk Management & Medical Affairs CROs (HLAGAAAH), Method Development & Validation (ICH/USP) (HLAGADAB)

Keywords

• Pharmaceutical consulting
• Impurity assessment
• Nitrosamine evaluation
• Regulatory compliance
• Toxicological evaluation

Headquarters

HQ city

Brazil

HQ country

Brazil

HQ region

Latin America

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Scientific Consulting Services: Provides technical-scientific evaluations supporting chemical safety decisions for health products. Services include impurity assessments, LEBS/PDE calculations, nitrosamine evaluations, training, and regulatory submissions.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels5 records

Core offering

Spektra Consultoria is a Brazilian scientific and regulatory consultancy that delivers technical-scientific evaluations supporting chemical safety decisions for pharmaceutical and health products. Its services cover non-mutagenic and potentially mutagenic impurity assessments, extractables and leachables evaluations, impurity formation studies, nitrosamine risk assessments, LEBS/PDE/OEL determinations, customized in-company training, and innovation support, all delivered using specialized in silico platforms combined with deep toxicology and pharmaceutical industry expertise.

Product overview

Spektra Soluções Científicas is a scientific and regulatory consulting firm providing expert technical-scientific evaluations that support chemical safety decision-making for pharmaceutical and health products. The portfolio centers on impurity assessment and pharmaceutical product safety, encompassing seven interconnected service areas: non-mutagenic impurity evaluation, potentially mutagenic impurity evaluation (using Derek/Sarah Nexus), extractables and leachables assessment (ICH Q3E), impurity formation studies, nitrosamine risk assessment (using Derek Nexus, Sarah Nexus, and Mirabilis for purge analysis), health-based exposure limits (LEBS/PDE and OEL) for cross-contamination control, and in-company training programs. Innovation services round out the offering, leveraging specialized in silico platforms including ASAPprime (FreeThink Technologies), Fusion QbD (S-Matrix), Zeneth, Derek Nexus, Sarah Nexus, and Mirabilis (all Lhasa Limited) for stability prediction, method/product development, degradation pathway modeling, and toxicity evaluation.

Differentiator

Problem solved

Functional benefit

Products and services

• Non-Mutagenic Impurity Assessment and Control Technical-scientific evaluation services for non-mutagenic impurities and contaminants in pharmaceutical products, supporting regulatory decision-making for ANVISA and other agencies.
• Potentially Mutagenic Impurity Assessment and Control Risk assessment services for potentially mutagenic impurities using in silico tools Derek Nexus and Sarah Nexus (Lhasa Limited) to evaluate mutagenic potential and support ICH M7 compliance.
• Nitrosamine Risk Assessment Comprehensive nitrosamine risk assessment including theoretical evaluation of formation potential and mutagenic character using Derek Nexus and Sarah Nexus, with purge factor analysis via Mirabilis for ICH M7 Option 4 control.
• Extractables and Leachables Assessment Evaluation and control of extractable and leachable substances from manufacturing systems, packaging, and drug delivery devices, addressing ICH Q3E guidelines.
• Impurity Formation Studies Investigation and assessment of impurity formation mechanisms during pharmaceutical manufacturing and storage, including degradation pathways and synthesis-related impurities.
• LEBS, PDE and OEL Determination Health-Based Exposure Limits (LEBS/PDE) and Occupational Exposure Limits (OEL) assessment services for cross-contamination control and worker safety in shared pharmaceutical manufacturing facilities.
• In-Company Training Programs Customized in-company training programs covering stability method development, forced degradation studies, mass balance, impurity toxicity evaluation, in silico toxicology approaches, compatibility studies, analytical method development (Fusion QbD), and stability studies (ASAPprime).
• Pharmaceutical Development Innovation Services Innovation support for pharmaceutical development using advanced in silico technologies including ASAPprime for stability prediction, Fusion QbD for method development, Zeneth for degradation/compatibility prediction, and Derek/Sarah Nexus for toxicity prediction, enabling efficient science-based product development aligned with QbD principles and Industry 4.0 approaches.

Quantifiable outcome

• 2000+ reports submitted to different regulatory agencies with no rejections
• +2 more outcomes

Named customers21 records

Segments1 record

Ideal customer profiles1 record

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration6 records

AI capability3 records

Feature7 records

Partnerships

Four partnerships are on record, tiered core.

• Consult LhasacoreStrategic or Co-development Partner · 1 December 2025In December 2025, Spektra announced it is now part of Consult Lhasa, marking a significant strategic milestone after 7 years of operation. This union combines two companies sharing the same principles and purposes, representing a strategic step in Spektra's evolution with benefits for clients, partners, and society.
• Lhasa LimitedcoreTechnology or IntegrationLhasa Limited (Leeds, UK) provides in silico toxicology software including Derek and Sarah Nexus for mutagenicity assessment and Mirabilis for purge factor calculations (ICH M7 option 4). Spektra represents Lhasa's tools in Brazil.
• S-MatrixcoreTechnology or IntegrationS-Matrix provides Fusion QbD software for method and product development used by Spektra for pharmaceutical development with greater productivity and assertiveness.
• FreeThink TechnologiescoreTechnology or IntegrationFreeThink Technologies provides ASAPprime software for accelerated stability prediction used by Spektra for pharmaceutical development studies.

Scale indicators4 records

Recent moves6 records

Expansion highlights6 records

Broad incumbents

• Charles River Laboratories: Large CRO offering safety assessment, regulatory toxicology, and impurity-related services. Comparable in toxicology domain but operates at a vastly larger scale with GLP laboratory infrastructure Spektra does not own.
• Lhasa Limited: Developer of Derek Nexus, Sarah Nexus, Mirabilis, and Zeneth — the in silico tools that form Spektra's core technology stack and now its parent company via Consult Lhasa. Both a strategic partner and broader incumbent in computational toxicology.
• Intertek Pharmaceutical Services: Global testing and regulatory services provider with pharmaceutical extractables/leachables, impurity, and stability offerings. Comparable to Spektra's E&L and method development work, but as part of a much wider testing services portfolio.
• NSF Health Sciences: Global consulting arm of NSF offering pharma regulatory, quality, and toxicology services including ICH M7/M7(R1) impurity assessments. Comparable to Spektra in service scope but at much larger scale and with broader geographic reach.
• IQVIA: Global CRO and consulting powerhouse offering regulatory, safety, and clinical services to pharma. Comparable customer base (major pharma companies) and regulatory submission expertise, though at a fundamentally different scale and breadth.
• Eurofins Pharmaceutical Services: Large network of contract laboratories and consulting services for pharma including impurity testing, stability, and regulatory support. Adjacent to Spektra's analytical and consulting work, but with significant laboratory infrastructure.

Direct peers

• PharmaLex (now Cencora PharmaLex): Global regulatory and scientific consulting firm offering pharmaceutical regulatory affairs, toxicology, and CMC services. Most directly comparable to Spektra's impurity assessment and regulatory submission work, but at significantly larger scale across multiple geographies.
• Lachman Consultant Services: US-based pharmaceutical regulatory and scientific consultancy specializing in FDA-related CMC, GMP, and impurity issues. Highly comparable to Spektra's boutique model of senior-led regulatory toxicology and impurity qualification.
• ToxServices: US-based toxicology consultancy providing hazard, exposure, and risk assessments including health-based exposure limits (PDE/OEL) for pharma — a direct service-line overlap with Spektra's LEBS/PDE/OEL practice.

Emerging players

• Toxys: Specialized toxicology CRO offering in vitro genotoxicity and reproductive toxicity assessments relevant to impurity qualification. Comparable niche toxicology focus, but with proprietary assays rather than in silico methods.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights6 records

Customer concentration

• YouTubeyoutube.com/@PasteurlariaPodcast
• LinkedInlinkedin.com/company/spektra-consultoria
• Instagraminstagram.com/spektra_solucoes_cientificas

Revenue estimate

Valuation estimate

Number of profiles

Profiles6 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 Spektra Consultoria