A growing business is directly proportional to the potentiality of the market.
- July 15, 2021 Food and Food Supplements, Regulatory Affairs
- July 14, 2021 Chemicals, Regulatory Artwork Services, Regulatory Affairs, Regulatory Labeling
The chemicals industry plays a pivotal role in producing petrochemicals, polymers, basic inorganics, specialities and consumer chemicals in Europe. European Chemicals Agency (ECHA) implements the EU’s chemicals legislation to protect health, safety and the environment. Classification, Labeling and Packaging (CLP) regulation helps in identifying hazardous chemicals and informs users throughout the EU about their hazards.
- July 13, 2021 Medical Devices
It is well known that the mandatory deadline for European Medical Device Regulation (EU MDR) was postponed to May 26, 2021, due to abrupt onset of COVID-19. In simple terms, the EU MDR aims to provide device clinical safety and effectiveness by establishing a robust, transparent and sustainable Regulatory framework that is recognized internationally and improves fair market access for manufacturers.
- July 13, 2021 Medical Devices
The medical devices undergo conformity assessment before they are included in the ARTG list to ensure that the devices comply with the essential principles required by the Therapeutic Goods Administration (TGA), Australia. Essential principles basically outline the safety and performance characteristics that any device should meet, so that it can be sold in Australia.
- July 13, 2021 Medical Devices
Mexico is considered as the second largest market for medical devices in Latin America. In Mexico, the Federal Commission for the Protection against Sanitary Risk (COFEPRIS) from the Secretariat of Health, regulates the Medical Device registrations and related services.
- July 8, 2021 Medical Devices, Regulatory Affairs
The Indian medical device industry has been recording significant growth and ranks in the top 20 markets for medical devices worldwide. It is estimated to reach USD 50 billion by 2025 from that of USD 10.36 billion in 2020.
- July 8, 2021 Regulatory Medical Writing
Regulatory writing discipline with its guidelines and regulations is considered complex. In addition, staying ahead of an ever-changing Regulatory environment for generic submissions and approvals is a tedious process.
- June 21, 2021 Medical Devices
The recent political changes between the Switzerland and European Union (EU) have significantly impacted the Medtech industry. With more than 1400 Medtech companies, the medical devices sector accounts for 3% of Switzerland’s GDP and provides employment for > 63,000 workforce. Switzerland exports medical devices worth > $5.6bn and the medical device imports from the EU account for $3bn.
- June 16, 2021 Pharmaceuticals, Regulatory Artwork Services
Pharmaceutical artwork is a highly regulated process, involving different regulations for multiple product portfolios. Despite the stringent regulations surrounding pharmaceutical packaging, artwork-related errors still exist and the potential for these errors is relatively high when the company relies solely on manual processes.
- June 10, 2021 Medical Devices
The Conformity Assessment Body (CAB) carries out the conformity assessment of various stakeholders of medical device supply chain system. The Conformity Assessment Body (CAB), Malaysia carries out extensive audits and evaluates all the applicable elements set by the Medical Device Authority (MDA), Malaysia and verifies the device conformity to the relevant standards.