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Testing & Services

Regulatory Services

APS offers comprehensive global regulatory consulting services for the medical device industry.  APS Regulatory Services will partner with your organization and support you through the regulatory process in the United States and major international markets by developing a plan to achieve timely medical device approvals and registrations.  Our capabilities include:

  • Strategic regulatory planning
  • Pre - Clinical Studies Strategy and Testing
  • Pre-market approval application (PMA)
  • Investigational device exemption (IDE)
  • Pre-market notification (510k)
  • Humanitarian device exemption (HDE)
  • Humanitarian device (HUD)
  • Expedited Access Pathway (EAP) for medical  devices normally subject to Premarket Approval (PMA) or De novo registration
  • FDA Device Registration and Listing
  • Device master files submissions
  • U.S Agent
  • Implementation of FDA eSubmitter electronic Medical device reporting (eMDR) establishment and implementation
  • Product development protocol (PDP)
  • Labeling Review
  • Interpretation of standards and guidelines
  • Preparation and representation at FDA advisory panels and regulatory agency meetings
  • Establishment Registration and device listings
  • Import/export certificates and registrations

Strategic Approach to Regulatory Planning

Strategic regulatory plan involves addressing many elements ranging from the relatively simple to the complex.

  • Device classifications and negotiation of device classification designation with regulatory agencies
  • Defining Intended use and indications for the medical devices
  • Defining Key product claims based on scientific evidence
  • Establishing possible predicate devices
  • Defining country specific regulatory pathways and possible regulatory risks
  • Defining applicable regulatory guidance documents
  • Interpreting technical standards and directives
  • Negotiation of device data development plans with regulatory agencies
  • Preclinical studies planning and negotiation with regulatory agencies
  • Establishing and reviewing labeling requirements and labels
  • Submission of device pre-market applications for approval
  • Establishment registration (for manufacturing sites) and device listings
  • Defining and supporting import/export requirements
  • Managing post approval modifications to product and manufacturing process

APS Regulatory Service consultants have successful attained approvals from major global regulatory agencies including but not limited to:

  • Food and Drug Administration (FDA) (United States )
  • European Union (CE mark)
  • Therapeutic Products Programme (TPP) (Canada)
  • Medicines and Healthcare Products Regulatory Agency (MHRA) (United Kingdom)
  • Ministry of Health, Labour and Welfare (Japan)
  • Therapeutic Goods Administration (TGA) (Australia)
  • State Food and Drug Administration (SFDA) (China)
  • Ministry of Health and Family Welfare (India)
  • Agência Nacional de Vigilância Sanitária (ANVISA) (Brazil)
  • COFEPRIS, Mexican division of the Ministry of Health (Secretaría de Salud) (Mexico)
  • National Food and Drug Surveillance Institute (INVIMA) (Colombia)
  • Ministry of Health (Costa Rica)
  • Dirección General de Medicamentos, Insumos y Drogas (DIGEMID) (Peru)
  • Asociación Nacional de Medicamentos, Alimentos y Tecnología (ANMAT) (Argentina)
  • Oficina de Inscripción Control de Equipos Médicos y Para Médicos (OICEM) (Venezuela)
  • National Institute of Hygiene and Tropical Medicine (ECUADOR)
  • Ministerio de Salud (URUGUAY)
  • Directorate of Medicines and Health Products (DIRMED) (El-Salvador)
  • Health Registration Law by the Dirección General de Servicios de Salud (GUATEMALA)

Take a look inside at the capabilities that APS has to offer...

American Preclinical Services (APS) is a State of the Art, ISO 17025 accredited, AAALAC accredited, USDA registered and GLP compliant Contract Research Organization (CRO) located in Minneapolis, MN.

We are a comprehensive CRO whose catalogue includes ISO10993, USP, USP, JMHLW, custom biocompatibility testing, interventional, surgical, toxicology, pharmacology, pain, cadaver and bioskills, model development and complete pathology services.

Whether your company is a startup or an established industry leader, APS’ experienced staff is uniquely qualified to tackle your project and meet your in-vivo and in-vitro preclinical research needs in a timely fashion. more