Biotech Pharma
Solutions
Integrated medical device, wound therapy, combination product, pharmaceutical and biologic technologies

Regulatory Affairs • Artificial Intelligence • Scientific Leadership

Complex health
technologies. Clear
regulatory direction.

Biotech Pharma Solutions brings regulatory strategy, clinical evidence, scientific leadership and governed AI together—from early decisions through submission and postmarket support.

Discuss a project Explore expertise
FDA EU MDR LATAM
25+ Years across regulated health technologies
100+ International patents
90+ Peer-reviewed publications
Global FDA, EU MDR and LATAM perspective

Core expertise

Science translated into regulatory progress.

Senior-level support for difficult programs, critical evidence decisions and high-stakes submissions.

01

Regulatory Affairs

Practical regulatory direction built around the product, the evidence and the business decision.

  • FDA 510(k), IDE and PMA strategy
  • IND, NDA, eCTD and CMC support
  • EU MDR 2017/745 strategy and technical documentation
  • LATAM regulatory strategy
  • Authority and Notified Body responses
  • Postmarket surveillance and FDA medical device reporting
02

Clinical Evidence

Evidence programs designed to withstand scientific, regulatory and commercial scrutiny.

  • Clinical Evaluation Plans (CEP)
  • Clinical Evaluation Reports (CER)
  • Summary of Safety and Clinical Performance (SSCP)
  • PMCF plans and PMCF Evaluation Reports
  • PMS Reports and Periodic Safety Update Reports (PSUR)
  • Systematic Literature Reviews and State of the Art (SOTA)
  • Evidence-gap, benefit-risk and traceable scientific writing
03

AI & Automation

Governed AI workflows that increase speed without surrendering traceability or expert judgment.

  • Regulatory evidence pipelines
  • Search, screening and extraction workflows
  • Structured content and document automation
  • Verification and audit-ready traceability
  • AI governance and explainability
  • Human oversight by design

Product & technology scope

Across the development continuum.

From a single evidence question to an integrated global program, support is shaped to the product and the decision at hand.

01

Medical Devices

Class I, II and III products

02

Implants & Interventional

Complex and high-risk technologies

03

Combination Products

Device, drug and biologic interfaces

04

Drug Delivery

Syringes, injectors and delivery systems

05

Wound Care

Advanced dressings and negative-pressure therapy

06

Drugs & Biologics

Development through lifecycle support

07

Digital Health

SaMD and data-enabled technologies

08

Global Programs

FDA, EU MDR and LATAM pathways

Scientific leadership

Mark Anderson,
PhD, RAC

Regulatory strategist, scientist and AI advisor

More than 25 years connecting rigorous science, regulatory strategy and product development across medical devices, pharmaceuticals, biotechnology and combination products.

01

Cross-functional leadership from early development through submission, approval and postmarket obligations.

02

Technical depth in clinical evidence, complex devices, therapeutics and scientific communication.

03

Applied AI strategy centered on governance, verification, traceability and accountable human oversight.

Teaching & training Inquire

Start a conversation

Bring the difficult question.

Share the product, regulatory challenge or evidence question. You will reach Biotech Pharma Solutions directly—no form, no scheduler and no mailing list.