Resch Consulting, LLC

Specializing in Regulatory Affairs Issues

Serving Medical Device Research Groups

 
        
 

Not ready to implement a full regulatory program?

        We can assist you with the initial regulatory start up activities.

Need reliable, temporary help for a short term project?

         We can provide assistance either as an independent contributor or regulatory lead.

Who we are:

          With 20 + years of experience in Domestic and International Regulatory Affairs, we specialize in helping research organizations and small manufacturers of medical products coordinate North American, European, Asian and Pacific Rim regulatory affairs and quality compliance activities

       

Gerda P. Resch

 resch@reschonline.com

    661-993-8080

 

Gerda Resch, Principal, is Regulatory Affairs Certified and is an American Society for Quality- Certified Quality Auditor

 

We can provide you with the necessary expertise and contacts to meet your startup needs, from product conception to meeting FDA requirements.

 

Strategic regulatory planning,

Label and SOP development;

510(k), IDE, PMA as well as CE (MDD and AIMD) and STED submission development,

  Do your standards and regulatory requirements searches (Materials of Animal and Human Origin, RF)
 

We can provide you with over 20 years experience in a wide variety of products, including medical devices, OTC products, biologics, and cosmetics.

 

Domestic and international compliance activities

Assist you in initiating your quality management system

Help you prepare your initial clinical and regulatory documentation

 

Recommend biocompatibility and microbiology protocols

Train staff in QSRs, GLPs, GCPs, cGMPs

 

We can provide training for new start-up companies, so that they can build their own regulatory affairs group, while being there to assist when needed.

      Prepare Essential Requirements Matrices
 

We can keep your costs low by maintaining the low overhead only a small firm can offer.

 

    Mailing Address:

     Resch Consulting, LLC

     195 Butts RD

    Portland, TN 37148 USA

 
    And much more……