consultant services

Atkinson Biologics Consulting has been providing value-added product development, clinical, regulatory and manufacturing services to medical companies since 2012.

Services include small projects that may  require one month to complete to large, complex, multi-faceted projects that require a retained, focused effort for one to several years.

I identify and fill gaps that exist within current teams and then integrate and contribute towards the company's goal.

Specific consultant services are listed below and includes support for spine and orthopedic hardware (fusion and arthroplasty) and for biologics. The biologics support includes substantial experience with the following: Biomaterials (collagen, hyaluronate, hydroxyapatite), recombinant proteins, human tissue allograft (amnion, viable cellular allograft, cartilage, adipose, dermis), cellular therapeutics (mesenchymal stem cells, CD34+, Regulatory T-cells), growth factors, and peptides.

Strategy to decrease development time and costs while minimizing risk and increase success rate.

Create product development plan including tasks, budgets, risks and timelines.

Design control.

Strategic guidance and write regulatory documents for: PreSub, IND/ NDA/ BLA, IDE/PMA, Master File, 510(k), CTD, Section 361 HCT/P.

Chemistry, Manufacturing and Controls (biomaterials, cellular therapies, peptides and recombinant proteins).

Write all parts of CER.

Senior reviewer for MDR compliance and quality.

Expertise in spine and orthopedic hardware.

Postmarket clinical support from protocol development through data analysis and manuscript writing (see publications tab). Includes Post Market Clinical Follow-up (PMCF) studies per MDR

IND/ IDE protocols