RTA has met with regulators in many major regulated countries, and has managed regulatory submissions on a worldwide basis. These have included, INDs, NDA’s, CTDs, ANDA’s, PMA’s 510k’s, Investigator Brochures, and Food Additive petitions or their international equivalent. Our results speak for themselves, e.g. all but one of our 510k’s was approved, Over 90% of our 510k’s have been approved within 90 days of submission. RTA has extensive experience in IND, NDA and CTD preparation and has completed the nonclinical safety portions of 7 CTDs. RTA is very active supporting the needs of the pharmaceutical and medical device industries and is a recognized expert in the area of female reproductive health. RTA is registered with the FDA as a US Agent.
A key ingredient in any product development program is an evaluation of adverse effects and safety. RTA has significant experience in the design, placement, conduct, monitoring and interpretation of preclinical studies and has a broad range of contacts and experience within the toxicology CRO industry. RTA has extensive experience in overall preclinical program management and can provide Study Director services on a contract basis
RTA has extensive experience in preclinical and clinical dermatology, reproductive health, and safety pharmacology. RTA has extensive experience in pharmacological and medical device claim substantiation and routinely consults in these areas.
RTA has been instrumental in assessing hazards in both the workplace environment as well as in the field including hazardous waste sites. We set occupational exposure limits for the workplace and assess hazards in the environment. RTA offers our expertise in the development of material safety data sheets (MSDS).
RTA routinely participates as a member of client drug and medical device development teams providing support and consultation regarding regulatory requirements and preclinical safety program design and management, study placement, study conduct and interpretation, summarization and regulatory filing. RTA also provides extensive medical writing services
RTA has advised in the development and monitoring of clinical studies specializing in clinical safety studies including repeated insult patch tests for allergy, comedogenicity, cumulative irritation, contraceptive efficacy and other related areas. RTA has an FDA compliant Institutional Review Board for clinical research for which Dr. Staab serves as the chairman.
RTA routinely provides due diligence services evaluating the feasibility of the successful registration of potential product acquisitions specializing in the assessment of product safety data packages. RTA has evaluated the integrity of data packages in support of regulatory submissions in various disciplines, cardiovascular, dermal, reproductive health, etc.
Program management in product stability, purity, and composition. Assessment of decomposition of materials, residuals in numerous products; e.g., food, plastics, and food containers. Analytical chemistry and pharmaceutical chemistry support for a wide range of development needs.