Outsourcing of Regulatory Professionals

Effective, Professional and Economical

During the development of a new drug or medical device, the R&D is required to work with a close and  professional regulatory guidance, from the early development (when strategic decisions regarding the product are made) through to the market launch. Regulatory personnel are the ones who check, monitor and adjust the product according to the Regulations or the Guidelines of the relevant authorized health authorities.

It is important that a local regulatory professional works close to the R&D center, keeps in constant communication with the researchers and engineers, and monitors all the development phases and their compatibility to the requirements of the FDA and the EMEA, in order to prevent possible future problems that may occur once filing the product for registration and certification.

LSA offers its clients local Israeli Ph.D owner regulatory professionals, with vast practical experience in senior scientific and executive management positions, at international pharmaceutical and medical device companies:

• For Medical Device Development: a regulatory expert with over 11 years of regulatory experience in registration and certification of medical devices in the US and Europe. Vast experience in senior executive positions of strategice regulatory pre-clinical and clinical planning, in several fields amongst them the cardiological, ophthalmological, gastroenterological, dental and other fields.
  
  
• For Drug Development: a regulatory expert with over 20 years of practical experience at the international pharmaceutical industry in senior scientific and executive management positions in R&D, bio-pharmaceutical pre-clinical, clinical trials and regulatory affairs at FDA and ICH levels.

In addition to the local Israeli regulatory expert it is important to use the services of local regulatory agencies at the target markets (Europe and the U.S.). These agencies are located close to the decision makers, are up-to-date with the ever changing rules and regulations, and know the local mentality and discussion culture, which are critical for receiving product certification.

LSA also represents local professional regulatory agencies at the target market. Click for details

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