BioPharma Global

What BioPharma Global does

BioPharma Global is a regulatory affairs consulting firm that specializes in guiding pharmaceutical and biotechnology companies through U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) regulatory processes, with a particular emphasis on orphan drug designations and rare disease therapies. The firm provides regulatory strategy development, submission preparation, and agency interaction support across the drug development lifecycle, and has additionally expanded into medical device regulatory services.

The company was founded by James LaFlamme (CEO) and Carolyn Thompson (Board Chair) and operates on a project-based, fixed-price consulting model. It serves clients ranging from early-stage biotechnology startups to multinational pharmaceutical corporations on a global basis. The firm claims more than 350 applications submitted for FDA designations and reports a 100% success rate when clients adhere to its guidance. Services are delivered in English and Chinese.

BioPharma Global was previously a wholly owned subsidiary of Merito Group and became a division of Pace Life Sciences in 2022. Its advisory board includes Marlene Haffner, former Director of the FDA Office of Orphan Products Development, which anchors the firm's regulatory credibility. No revenue, headcount, or funding data are disclosed.

Name

BioPharma Global

Legal name

BioPharma Global

Website

https://biopharmaglobal.com

Company type

Private

Founded year

2017

Operating status

Operating

Headcount range

1–10 employees

Short description

BioPharma Global is a regulatory affairs consulting firm that prepares and submits FDA and EMA applications for orphan drugs, rare disease therapies, and medical devices, serving biotech startups through multinational pharmaceutical firms on a fixed-price project basis.

Ownership category

akta.pro rank

Product category

Regulatory Affairs Consulting

NAICS

Scientific Research and Development Services (5417), Research and Development in Biotechnology (except Nanobiotechnology) (541714)

SIC

Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

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

akta.pro secondary industries

Regulatory Strategy & IND/NDA/BLA Submissions Support (HLAIALAH), Small-Molecule CMC Documentation & Regulatory Support (DMF/CMC) (HLAGAHAM)

Keywords

• Regulatory affairs consulting
• Orphan drug designation
• FDA EMA submissions
• Rare disease drug development
• Medical device regulatory

Headquarters

HQ city

Vienna

HQ country

United States

HQ region

North America

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Regulatory Affairs Consulting Services: The company provides regulatory consulting services including FDA and EMA regulatory strategy development, submissions, orphan drug designations, IND filings, and comprehensive regulatory project consulting. Revenue is generated through project-based fixed-price consulting engagements.

Pricing tiers

Go-to-market motion1 record

Distribution channels1 record

Marketing channels4 records

Core offering

BioPharma Global is a full-service regulatory affairs consulting firm that provides FDA and EMA regulatory strategy, submissions, orphan drug designations, expedited program applications, IND/NDA/BLA filings, eCTD preparation, CMC guidance, and medical device regulatory support. The firm serves drug and device developers globally, ranging from small biotech startups to multinational pharmaceutical corporations, with a particular specialization in orphan drugs and rare disease therapies.

Product overview

BioPharma Global is a full-service regulatory affairs consulting firm that provides a comprehensive portfolio of regulatory consulting services to help drug and device product developers advance treatments through FDA and EMA approval processes. The company's service offerings span the entire drug development lifecycle, from early-stage regulatory strategy and orphan drug designations through to New Drug Applications and Biologics License Applications. Key services include FDA and EMA applications (Orphan Drug Designation, IND, NDA, BLA, Fast Track, Breakthrough Therapy, Rare Pediatric Disease), medical device regulatory affairs (510(k), PMA, De Novo), and strategic consulting (CMC review, FDA/EMA meeting preparation). The company specializes in orphan products for rare diseases and serves clients ranging from small biotech startups to multinational corporations. BioPharma Global operates as a division of Pace Life Sciences and is a wholly owned subsidiary of Merito Group.

Differentiator

Problem solved

Functional benefit

Products and services

• Regulatory Strategy Development Consulting service providing strategic reviews of pre-written applications, gap analysis, FDA and EMA meeting preparation and attendance, feasibility assessments, and CMC review and guidance for drug development programs targeting rare diseases and unmet medical needs.
• Regulatory Affairs Submissions Comprehensive support for FDA and EMA regulatory submissions including document preparation and filing services for applications such as Orphan Drug Designation, IND, NDA, BLA, Fast Track, Breakthrough Therapy, Rare Pediatric Disease, and related expedited programs.
• Orphan Drug Consulting Specialized consulting services supporting drug developers in obtaining FDA and EMA Orphan Drug Designations for treatments targeting rare diseases and underserved patient populations.
• Rare Pediatric Disease Designation Assistance with obtaining FDA Rare Pediatric Disease Designations and associated Priority Review Vouchers for drugs and biologics intended to treat rare pediatric diseases.
• eCTD Guidance & Submission Electronic Common Technical Document (eCTD) guidance and submission services for regulatory filings to FDA and EMA, including document preparation, publishing, and electronic submission management.
• IND Application Investigational New Drug (IND) application preparation, submission, and regulatory support services for drug developers seeking to begin clinical trials in the United States.
• Guidance for Chemistry, Manufacturing, and Controls (CMC) Chemistry, Manufacturing, and Controls (CMC) review and guidance services covering drug substance and drug product manufacturing, quality control documentation, and regulatory submission support.
• Fast Track Designation Consulting services to obtain FDA Fast Track Designation for expedited drug development and review of therapies addressing serious conditions with unmet medical needs.
• Breakthrough Therapy Designation Support for obtaining FDA Breakthrough Therapy Designation and preparing preliminary breakthrough therapy requests for drugs showing substantial improvement over existing therapies.
• New Drug Application (NDA) Preparation and submission of New Drug Applications (NDAs) to the FDA for drug approval, including document compilation, regulatory strategy, and FDA interaction support.
• Biologics License Application (BLA) Regulatory support for Biologics License Application (BLA) preparation and submission to the FDA for biologic products seeking U.S. marketing approval.
• Medical Device Regulatory Affairs Comprehensive regulatory affairs services for medical devices and combination products, including IDE- and PMA-enabling gap analysis, 510(k), Premarket Approval (PMA), De Novo Classification Requests, Humanitarian Device Exemption (HDE), Humanitarian Use Device (HUD), Investigational Device Exemption (IDE), Pre-Submission meetings, and Breakthrough Therapy Device Designation.

Quantifiable outcome

• 100% success rate on FDA applications when clients follow BioPharma Global guidance
• +1 more outcomes

Segments1 record

Ideal customer profiles1 record

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Partnerships

Three partnerships are on record, tiered core.

• Pace Life SciencescoreOthersBioPharma Global is now a division of Pace Life Sciences. This is a structural/corporate relationship where BioPharma Global operates as a division within the larger Pace Life Sciences organization.
• Merito GroupcoreOthersBioPharma Global is a wholly owned subsidiary of Merito Group. This represents a corporate ownership structure where Merito Group holds full ownership of BioPharma Global.
• Marlene Haffner, MD, MPH (Advisory Board)coreOthersMarlene Haffner, former Director of the FDA Office of Orphan Products Development (OOPD), serves on BioPharma Global's Advisory Board. Her regulatory expertise in orphan drug affairs strengthens the company's advisory capabilities.

Scale indicators3 records

Recent moves5 records

Expansion highlights3 records

Broad incumbents

• Parexel International: Parexel is a global CRO offering comprehensive regulatory consulting, clinical development, and post-approval services. It is a broad incumbent peer because it competes with BioPharma Global on regulatory strategy and submissions but primarily serves large pharma.
• Charles River Laboratories: Charles River Laboratories is a broad life sciences services firm with regulatory and drug development consulting capabilities. It overlaps with BioPharma Global in CMC regulatory support and IND/NDA strategy but offers much wider preclinical and manufacturing services.
• IQVIA: IQVIA is the world's largest CRO with a full-service regulatory affairs offering spanning FDA/EMA submissions, pharmacovigilance, and clinical strategy. It is a broad incumbent peer because it overlaps with BioPharma Global's regulatory consulting but also delivers clinical, data, and commercial services at much greater scale.

Others

• Pace Life Sciences: Pace Life Sciences is the parent organization of which BioPharma Global is a division, providing scientific services including analytical chemistry, CMC, and life sciences staffing. It is thematically and structurally related as the corporate parent rather than a market competitor.

Direct peers

• Key Tech (a Medical Device CRO): Key Tech is a medical device development and regulatory consulting firm supporting 510(k), PMA, IDE, and De Novo submissions. It directly competes with BioPharma Global's Medical Device Regulatory Affairs service line.
• PharmApprove: PharmApprove is a regulatory strategy and FDA meeting preparation consultancy supporting biotech and pharma sponsors. It directly competes with BioPharma Global's regulatory strategy development and FDA/EMA meeting preparation services.
• ProPharma Group: ProPharma Group is a regulatory affairs, pharmacovigilance, and compliance consulting firm serving pharma, biotech, and medical device clients. It is a direct peer to BioPharma Global in FDA/EMA regulatory strategy, submissions, and CMC consulting for small to mid-sized drug developers.
• Camargo Pharmaceutical Services: Camargo Pharmaceutical Services is a regulatory consulting firm specializing in 505(b)(2) and ANDA pathways, NDA/IND strategy, and CMC. It is a direct peer to BioPharma Global in drug regulatory affairs consulting for emerging pharma companies.
• NDA Partners: NDA Partners is a regulatory consulting firm composed of former FDA reviewers and industry experts that supports drug development submissions. It directly competes with BioPharma Global on regulatory strategy, NDA/BLA, and expedited program consulting for biotech clients.
• Coté Orphan: Coté Orphan is a regulatory consulting firm specializing in rare disease and orphan drug development support, similar in focus and customer profile to BioPharma Global. BioPharma Global's CEO previously served as Executive Vice President at Coté Orphan, making it a closely comparable peer with shared leadership heritage.

Market position

Strengths4 records

Weaknesses5 records

Competitive moat3 records

Key risks5 records

Key highlights6 records

Customer concentration

• Xx.com/biopharmaglobal
• LinkedInlinkedin.com/company/biopharma-global

Revenue estimate

Valuation estimate

Number of profiles

Profiles14 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 BioPharma Global