Market Analysis – Health Regulation in United States of America
A strategic planning is required when you want to insert a new product in a market, because depending the regulatory bureaucracy of each country, its absence may result in delays, high costs and disruption imposed by the local regulatory bodies.
If your company wants to introduce a new product in the United States, must be attentive to the requirements established by Food and Drug Administration (FDA). Advances are being made toward the search for a Global Harmonization, however, there are still many obstacles that end up making the regularization of the product and its commercialization a complex and bureaucratic process.
Backed by a team with a marketing knowledge, the Passarini Regulatory Affairs offers to its clients a partnership to identify which will be the best strategy taking into consideration the market and its compliance needs.
We count with an extensive network of consultants in the world to evaluate all regulatory requirements, of each significant market, any product of your company’s interest, with the intention to provide the following information:
- Study and market research, aiming a better acceptability of the product;
- Evaluation of the technical characteristics of each product;
- Product classification;
- Check-list contemplating the documents required for the submission of the request for registration;
- Internal Representation;
- Labelling Adjustment;
- Cost Estimation;
- Time Prediction for regularization of the product;
- Post-Market Requirements.
Moreover, the Passarini Regulatory Affairs develops an analysis customized to meet a specific need as per request of each customer.
Regulatory Check- List:
The Passarini Regulatory Affairs offers to its customers a check-list with the aim of facilitating the regularization of each product. This procedure is intended to simplify the development of the technical dossier to be submitted before the Regulator Body.
For being a complete document and with the help of one of our specialized consultants, the product registration will be granted in a timely manner attending the needs of your company.
Contact us so we can present our consultancy services and regulatory advice.