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Regulatory Consultancy

Expert guidance for seamless approvals.

Regulatory hurdles can delay or derail even the most promising drug development programs. At Biomapas, our expert regulatory consultants help pharma and biotech companies develop, refine, and execute regulatory strategies that align with agency expectations, ensuring smooth market access while minimizing delays and costs. 

Strategic Guidance from Early Clinical to Approval

Our regulatory consulting team provides end-to-end support tailored to your specific development needs. Whether you’re bringing a first-in-class therapy to market, repurposing an existing molecule, or navigating biosimilar approvals, our experts will guide you through: 

Regulatory Roadmap Development

A strategic plan from early-stage research to market authorization.

Clinical Development Strategy

Ensuring clinical trial designs meet regulatory standards for successful approval.

Chemistry, Manufacturing & Controls Consultations

Expert guidance on Chemistry, Manufacturing & Controls (CMC) compliance.

Regulatory Authority Engagement

Managing pre-submission meetings, scientific advice, and regulatory responses with EMA, FDA, MHRA, LATAM, Health Canada and national authorities.

Orphan Drug & Expedited Pathways

Navigating PRIME, accelerated assessment, conditional approvals, and Orphan Drug Designations.

Experience Thoughout Drug Development

Biomapas’ network of regulatory experts brings decades of experience across global markets. Our consultants have first-hand expertise in securing approvals from EMA, FDA, MHRA, Health Canada and other national authorities, ensuring your regulatory strategy is aligned with agency expectations. 

What to expect from a Biomapas Regulatory Consultant?

✓ Over 30 years of hands-on experience in regulatory strategy

✓ Proven success in securing global approvals

✓ In-depth knowledge of accelerated regulatory pathways

✓ Extensive clinical development expertise across all phases

✓ Compliance leadership from early phase to commercialization

✓ Broad experience across multiple therapeutic areas

✓ Modalities form small molecules to biologics and ATMPs

✓ Strategic CMC consulting to support development and scale-up

✓ Quality consulting for market access

Why Biomapas?

Unlike traditional consultancy companies, Biomapas offers a hands-on, integrated approach, combining regulatory expertise with strategic business insight. We don’t just provide advice, we work alongside your team to create differentiated, sustainable, and compliant regulatory strategies that give your product a competitive edge.

Take Control of Your Regulatory Strategy

Your regulatory decisions shape your commercial success. Let Biomapas help you avoid delays, mitigate risks, and accelerate approvals. Contact us today to discuss how our regulatory consulting services can support your development program. 

Learn how

Big Enough To Cover  All Your Needs. Small Enough To Care.

Discover the tailored solutions that Biomapas provides to accelerate your clinical trials and optimize your drug development process.
Affiliate-Based Outsourcing
CSV For Pharmacovigilance Systems
Early Phase Oncology
Functional Service Provision
M&A Support

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