Life Sciences & Healthcare Services

The increasing concern with human life and health protection has expanded the government’s controlling outreach, and the pharmaceutical industry is consequently facing more challenges. The medical device and products sector has also undergone substantial regulatory and business model changes, prompting a growing demand for specialised knowledge founded upon both international experience and intuition about the public sector’s behaviour when confronted with specific circumstances. Although market control of pharmaceuticals, medical devices and hygiene products rests upon a single entity, their regulatory frameworks are substantially different.

• Pre-market authorizations for products and other licenses.
• Pre-market authorizations and regulatory compliance for production facilities, wholesale distributors, drugstores.
• Electronic procedures and Single Window.

Private healthcare services operate in a tightly and ever-changing regulated environment, consisting of controls from different levels of government, and intricate proceedings that include the Ministry of Health, SuSalud, as well as regional and municipal authorities.

Our firm advises health care services, insurance funds as well as those that provide medical support services. We advise these organisations on the regulatory aspects of their operation as well as their coordination with pharmaceutical controlling agencies. Our partners have been consultants to the regulatory authority in Perú (Digemid) regarding administrative simplification and to the Presidency of the Cabinet of Ministers as to regulatory quality in the health sector.

• Licences for health facilities and regulatory compliance.
• Pre-market authorizations and acquisition of pharmaceutical products and medical.
• Solid waste management and environmental related issues.
• Telemedicine and other forms of remote health care service supply.
• Clinical Trials.
• Inspection of health care services facilities.