Novopharma

What Novopharma does

Novopharma is a private Mexican pharmaceutical and healthcare consulting firm headquartered in San Pedro Garza García, Nuevo León. Founded in 2021 with a stated 1-10 employee base, the company provides integrated advisory services to pharmaceutical companies, contract research organizations (CROs), medical device companies, biotechnological product firms, research centers, and public institutions operating in or entering the Mexican market.

The service portfolio spans the full pharmaceutical product lifecycle: regulatory affairs management before COFEPRIS, clinical trial monitoring across all phases (including early-phase trials via a network of Clinical Research Associates with more than 15 years of experience), interchangeability and bioequivalence testing under NOM-177-SSA1-2013, pharmacovigilance under NOM-220-SSA1-2016, quality management systems aligned with ISO 9001/14001/31000 and the newer ISO 7101:2023 healthcare standard, GCP auditing, dedicated clinical trial startup services, professional training, and importation of test/reference medications. Operational tooling includes a real-time project management platform that tracks global and per-site recruitment, monitoring visits, and notifications, paired with a risk-based monitoring methodology that prioritizes higher-risk sites for on-site visits. The firm also signals working familiarity with FDA and ICH frameworks, evidenced by display of FDA and ANVISA logos on its website.

The business model is professional services and sales-led: Novopharma delivers tailored, project-based consulting engagements directly to enterprise clients through quote-based pricing with no public price disclosure. Distribution is direct, with no intermediaries, and geographic coverage spans all Mexican territory with stated ambition to serve Latin American clients. Marketing is organic and top-of-funnel oriented, anchored by a regulatory and clinical content blog and a presence on LinkedIn, Facebook, and Instagram, with bottom-of-funnel conversion via direct contact and consultation request forms. No funding rounds, acquisitions, partnerships, named customers, or revenue figures are disclosed.

Name

Novopharma

Legal name

Novopharma

Website

https://novopharma.com.mx

Company type

Private

Founded year

2021

Operating status

Operating

Headcount range

1–10 employees

Short description

Novopharma is a private Mexican pharmaceutical consulting firm headquartered in San Pedro Garza García, providing COFEPRIS regulatory affairs, clinical monitoring, interchangeability testing, pharmacovigilance, and quality management advisory services to pharma companies, CROs, medical device firms, biotechs, and public institutions across Mexico and Latin America.

Ownership category

akta.pro rank

Product category

Pharmaceutical Consulting Services

NAICS

Administrative Management and General Management Consulting Services (541611)

SIC

Services-Management Consulting Services (8742)

akta.pro industry

PRIMARYHLAIABAJ

Generic ANDA/Regulatory Affairs & Submissions

Healthcare & Life Sciences/Pharmaceuticals/Generic Pharmaceuticals

SECONDARYHLAGAKAH

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

Healthcare & Life Sciences/Life Science Tools & Services (CRO/CDMO/Lab Services)/Regulatory Affairs, Quality & Compliance Services (GxP)

Keywords

• Pharmaceutical consulting
• Regulatory affairs
• Clinical monitoring
• Pharmacovigilance services
• Bioequivalence testing

Headquarters

HQ city

Monterrey, Nuevo Leon

HQ country

Mexico

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. Regulatory and Clinical Consulting Services: Novopharma generates revenue through advisory and consulting engagements for pharmaceutical companies, CROs, and healthcare institutions. Services cover regulatory affairs, interchangeability testing, clinical monitoring, pharmacovigilance, quality management systems, and training. Engagement models appear to be project-based consulting with personalized service delivery.

Go-to-market motion1 record

Distribution channels2 records

Marketing channels5 records

Core offering

Novopharma is a pharmaceutical consulting and advisory firm that provides integral solutions for pharmaceutical companies, CROs, medical device companies, biotechnological product companies, and public institutions. Its core services span interchangeability studies, clinical monitoring, regulatory affairs before COFEPRIS, pharmacovigilance, quality assurance, GCP audits, and clinical trial startup support across the Mexican territory.

Product overview

Novopharma is a strategic partner offering integral consulting and advisory services for pharmaceutical companies and the health sector. The company provides a comprehensive suite of services organized around clinical research support and regulatory affairs: Intercambiabilidad (interchangeability studies), Consultoría (personalized advisory), Capacitación (professional training), Estudios de Fases (phase studies), Aseguramiento de Calidad (quality assurance under ISO standards), Farmacovigilancia (pharmacovigilance), Importación (medication/material importation), Asuntos Regulatorios (regulatory affairs before COFEPRIS), Monitoreo Clínico (clinical monitoring with over 15 years of experience), Auditoría BPC (GCP auditing), and Startup Unit (clinical trial startup services). These services work together to support pharmaceutical companies, CROs, medical device companies, and public institutions through all stages of clinical research and regulatory compliance.

Differentiator

Problem solved

Functional benefit

Products and services

• Intercambiabilidad (Interchangeability) Services related to demonstrating drug interchangeability, including research site selection, ethics committee submission, clinical and analytical study monitoring, and review of clinical, analytical, and pharmacokinetic reports. Targeted at pharmaceutical companies seeking Mexican regulatory approval for generic drugs.
• Consultoría (Consulting) Personalized advisory services covering medical office licensing, pharmacy guidance, quality system implementation for ethics and research committees, and interchangeability consulting. Serves pharmaceutical companies and healthcare institutions.
• Capacitación (Training) Professional training programs covering clinical research, Good Clinical Practices, interchangeability and bioequivalence, and development and validation of bioanalytical methods. For pharmaceutical and clinical research professionals.
• Estudios de Fases (Phase Studies) Regulatory advisory and research/ethics committee selection and monitoring services for clinical trial phases. For pharmaceutical companies and research centers running clinical trials in Mexico.
• Aseguramiento de Calidad (Quality Assurance) Quality assurance services aligned with ISO 9001-2015, ISO 14000-2015, and ISO 31000-2018 standards for quality management and risk management. Serves pharmaceutical companies seeking quality system certification.
• Farmacovigilancia (Pharmacovigilance) Adverse event detection, evaluation, and prevention services including risk management plan development, event analysis and classification, and safety reporting. For pharmaceutical companies with marketed products in Mexico.
• Importación (Importation) Import services for test and reference medications, health supplies, and raw materials for clinical trials. Supports clinical trial sponsors with logistics and customs handling.
• Asuntos Regulatorios (Regulatory Affairs) Management of regulatory procedures before COFEPRIS for sanitary registry and product commercialization in Mexico. For domestic and international pharmaceutical companies.
• Monitoreo Clínico (Clinical Monitoring) Clinical trial monitoring services covering all trial phases with risk-based monitoring and project management tools. Backed by Clinical Research Associates with over 15 years of experience.
• Auditoría BPC (GCP Audit) Good Clinical Practices (GCP) audit services to verify compliance with research protocols, ethical principles, regulations, and standard operating procedures. Serves sponsors and CROs running clinical trials.
• Startup Unit Clinical trial startup services including regulatory agency and ethics committee submissions, documentation management, and center activation within client deadlines. For clinical trial sponsors entering the Mexican market.

Quantifiable outcome

• Studies in which Novopharma has participated have successfully passed BPC (Good Clinical Practices) audits by clients
• +1 more outcomes

Segments6 records

Ideal customer profiles4 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Scale indicators3 records

Recent moves5 records

Expansion highlights4 records

Direct peers

• Pharmalex: Global regulatory affairs and pharmacovigilance consultancy serving pharma companies on submissions, lifecycle management, and quality compliance. Highly comparable to Novopharma's regulatory affairs and PV service lines, though operating at a much larger, multi-region scale.
• ProPharma Group: Pharmaceutical and medical device compliance, regulatory affairs, and quality consulting firm. Comparable to Novopharma's mix of regulatory affairs, quality management systems, and compliance consulting for pharma and medical device clients.
• MakroCare: Global CRO and regulatory services provider offering clinical monitoring, bioequivalence, regulatory affairs, and pharmacovigilance across multiple geographies. Direct competitor in the same functional services Novopharma provides.

Broad incumbents

• IQVIA: The world's largest CRO with full-service clinical, regulatory, and PV capabilities including LATAM operations. Competes for the same pharma clients as Novopharma but at vastly larger scale and with proprietary technology platforms.
• ICON plc: Major global CRO providing clinical research, regulatory, and laboratory services with established LATAM presence. Competes for clinical monitoring and regulatory affairs work that Novopharma also pursues.
• Parexel: Global CRO with comprehensive clinical, regulatory, and pharmacovigilance offerings. Direct overlap with Novopharma's clinical monitoring and regulatory affairs service lines, particularly for trials running in Mexico and LATAM.
• Syneos Health: Large contract research organization providing clinical development, regulatory, and commercialization services globally. Comparable to Novopharma in clinical monitoring and regulatory offerings, though at enterprise scale.
• Worldwide Clinical Trials: Mid-to-large global CRO offering clinical trial management, bioequivalence, and regulatory consulting. Overlaps with Novopharma on Phase I-IV monitoring and bioequivalence/interchangeability work, including for LATAM sponsors.
• Charles River Laboratories: Global CRO and preclinical/research services provider with regulatory and safety divisions. Comparable to Novopharma's clinical monitoring and pharmacovigilance capabilities, scaled to enterprise pharma sponsors.

Emerging players

• Clinipace Worldwide: Mid-sized CRO with therapeutic expertise and regulatory services for emerging biopharma sponsors. Comparable in service mix to Novopharma but positioned primarily in the U.S., with select international operations.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat4 records

Key risks5 records

Key highlights6 records

Customer concentration

• Facebookfacebook.com/novopharmamx
• LinkedInlinkedin.com/company/novo-pharma
• Instagraminstagram.com/novopharma

Compliance6 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 Novopharma