Regulatory Compliance Associates Inc. of Pleasant Prairie at MEDICA 2017 in Düsseldorf -- MEDICA Trade Fair
Service

Regulatory Compliance Associates Inc.

10411 Corporate Drive, Suite 102, 53158 Pleasant Prairie
United States of America

Telephone +1 262 288-6300
Fax +1 262 842-1240
info@rcainc.com

This company is co-exhibitor of
Messe Düsseldorf North America

Hall map

MEDICA 2017 hall map (Hall 16): stand D20-9

Fairground map

MEDICA 2017 fairground map: Hall 16

Our range of products

Product categories

  • 07  Medical Services and Publications
  • 07.01  Reports and analyses
  • 07  Medical Services and Publications
  • 07.04  Professional institutions
  • 07  Medical Services and Publications
  • 07.04  Professional institutions
  • 07.04.01  Associations and organisations
  • 07  Medical Services and Publications
  • 07.08  Logistic services
  • 07  Medical Services and Publications
  • 07.08  Logistic services
  • 07.08.06  Consulting for health organisations

Our products

Product category: Reports and analyses, Professional institutions, Associations and organisations, Logistic services, Consulting for health organisations

Services: Medical Devices

Below is a short list of services we offer to the medical device industry.
  • Project Management
  • Validation
  • FDA Inspection Readiness
  • Regulatory Submissions
  • Warning Letter Response
  • Design Control
  • Product Development
  • Quality Systems
  • DHF + Technical • DHF + Technical File » View Services
  • Remediation
  • Quality + Regulatory Training
  • GxP
  • M&A and Post-Merger Integration
  • Quality and Supplier Audits

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Product category: Reports and analyses, Professional institutions, Associations and organisations, Logistic services, Consulting for health organisations

Services: Pharmaceutical

Below is a short list of services that we offer to the pharmaceutical industry.
  • Process Validation
  • Project Management
  • Risk Management
  • Regulatory Strategies
  • Submissions & Registrations
  • Quality Systems Remediation
  • Quality & Supplier Audits and Inspection Readiness
  • Merger Integration
  • Product Development Practices/Clinical Practices
  • Training

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Product category: Reports and analyses, Professional institutions, Associations and organisations, Logistic services, Consulting for health organisations

Services: Regulatory Affairs

Regulatory Compliance Associates Inc. (RCA) develops regulatory strategy, implements plans, and remediates regulatory challenges. Regulatory Affairs is our backbone, and we handle more submissions in a month than many manufacturers do in a lifetime. RCA has experience working with notified bodies worldwide, therefore you can count on us for in-depth and up-to-date insights which increase speed-to-market.
Pharmaceutical Industry

NEW DRUG PRODUCTS SERVICES:
  • New Drug Application – NDA
  • Submission of the NDA documentation
  • Expertise in drug substance, drug product, manufacturing, labeling, container closure, supplier requirements, quality assurance, technical writing requirements, etc.
  • Experience with FDA & international bodies
ABBREVIATED NEW DRUG PRODUCTS SERVICES:

  • Generic Drug – ANDAs
  • Expertise in SPL requirements and analysisof innovator labeling
INVESTIGATIONAL NEW DRUG SERVICES:

IND and product development /scale up
Completion of IND documentation and transition to support the NDA documentation
Qualify clinical requirements, the manufacturing process and controls of the new compound.

LIFE CYCLE MAINTENANCE SERVICES:

  • Post NDA/ANDA approval activities
  • Services for existing pharmaceutical products currently on the market, e.g. DMF Annual Reports/Amendments or labeling
  • Changes to supplier sourced material, e.g. API
  • Changes to meet new agency Publishing requirements
 
Medical Device Industry

GLOBAL MARKET ENTRY REGULATORY SERVICES:

  • Product Classification Reports
  • Global Regulatory Strategy
  • Pre-Submission (Pre-Sub) Packages / Pre-Submission Meetings with FDA
  • 513(g) Request
  • Regulatory Procedures
GLOBAL REGULATORY SUBMISSIONS SERVICES:

  • Site Registration
  • Traditional Regulatory PathwaysPremarket NotificationTraditional 510(k)
  • Special 510(k)
  • Abbreviated 510(k)
  • Premarket Approval (PMA)Traditional (PMA)
  • PMA Supplement & AmendmentsPMA Supplement (180 days)
  • Special PMA Supplement — Changes Being Effected
  • 30-day Notice and 135 PMA Supplement
  • PMA Manufacturing Site Change Supplement
  • Annual (periodic) Report or 30-day Supplements
  • Modular (PMA)
  • Product Development ProcessProduct Development Protocol
  • Innovative Regulatory PathwaysDe Novo Request510(k) to De Novo
  • Direct De Novo
  • Humanitarian Use Device (HUD)
  • Humanitarian Device Exemption (HDE)
  • International Regulatory Package
  • Submission Intervention & RemediationResponse to FDA Additional Information (AI) Request
PRE-MARKET REGULATORY SERVICES:

  • Regulatory Planning
  • Support during design control
  • Labeling planning
REGULATORY MAINTENANCE SERVICES:

  • Product Regulatory Gap Assessment
  • Regulatory Change Strategy

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About us

Company details

Who We Are
Regulatory Compliance Associates Inc. (RCA) is a team of experienced professionals from FDA-regulated industries including pharmaceutical, biologics and medical device. Our team has navigated the front lines in Quality, Regulatory Affairs, Operations, Manufacturing and R&D. RCA is your partner for sustainable compliance in the United States and around the world.

What We Do
RCA brings full-spectrum solutions to compliance, regulatory, quality assurance, R&D and operational challenges for life science clients. RCA offers top-tier strategic planning, mid-level project management and hands-on support to provide a customized action plan to meet our clients’ needs, on time and on budget.

Resources We Provide
RCA is active in the regulatory, compliance and quality community and seek opportunities to share our thought leadership. 

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