Artwork design is an essential process in the supply of a pharmaceutical product which basically ensures patient safety while reducing recall risk.
- July 7, 2015 Regulatory Artwork Services, Regulatory Labeling
- June 16, 2015 Regulatory Affairs, Regulatory Medical Writing
A Medical writer plays a prominent role in writing various non-clinical and clinical documents related to drug approval from health authorities, in order to bring it to the market for making them accessible to the customers. Medical writer needs to produce high quality documents in a short time.
- June 10, 2015 Regulatory Consulting
Outsourcing has become an increasingly common practice in the Pharma and Biotech industry more so in the area of regulatory affairs and Pharmacovigilance.
- May 24, 2015 Cosmetics Regulatory Services
Cosmetic products have an estimated worth of €67bn in Europe, which is regarded as a massive enterprise. The primary requirement during the development of a cosmetic product is to ensure protection for the user’s health which is also the basis of the cosmetic legislation. This protection also enables increased consumer confidence in the brand.
COSMETIC LEGISLATION
- May 15, 2015 Medical Devices, Consumer Healthcare, Regulatory Labeling
Pharmaceutical and medical device industries are constantly changing with developing supply chain themes and technological advancements due to which labeling must be looked upon with a new perspective. A host of latest trends have compelled Pharmaceutical and medical device industries to rethink, strategize and streamline processes, meet compliance norms and start and learn best practices.
- April 9, 2015 Pharmaceuticals, Regulatory Consulting
Ever since the inherent risk in the marketing of medical devices and drugs increased, establishment of a tailor-made regulatory strategy for business success has been the call of the hour. The global environment has become pervasive because of the growing complexity in the pharmaceutical devices. Ultimately the regulation and market adoption of those avant garde drug/devices have adopted the same speed.…
Ever since the eCTD submission became mandatory by FDA in 2008, the life sciences industry has been facing certain difficulties in regulatory processes. Even though the electronic common technical document has been of great help in managing huge volumes of important documentation; there are a few glitches that complicate the submission process for the organizations.
- April 2, 2015 Pharmaceuticals, Regulatory Affairs, Regulatory Consulting
It’s no strange for everyone who is into regulatory intelligence services that a well-proportioned regulatory strategy plays a key role in boosting the opportunity of regulatory approval. Now a regulatory plan is also equally important which helps in meeting the objectives of the regulatory approval process.
- April 2, 2015 Pharmaceuticals, Medical Devices, Consumer Healthcare, Publishing & Submissions
Today regulatory terms like eCTD, ASPPs, CANDA, SPL, MAA and NDA to name a few are the buzz words in the world of regulatory compliance. While each terminology indicates the inception of the cutting edge technology; they also come with some downright challenges for the life sciences companies.
- March 17, 2015 Regulatory Affairs
Emerging markets in Asia Pacific, Latin America and Eastern Europe are increasingly important locations for drug development as sponsors pursue multinational programs to gain access to appropriate patient populations. And regulatory intelligence plays a crucial role in drug development and regulatory strategy.