Pharmaceuticals, Cosmetics & Medical Devices
of Medical Devices
The medical device industry is heavily regulated. In order to get your medical devices out in the market, you needs to achieve medical device compliance. In situations where a manufacturer fails to adhere to the set standards and meet the compliances, the future of the medical device can be compromised. In most situations, these manufacturers have to prove FDA as well as ISO compliances. The stakes are extremely high when it comes to approval of medical devices. Failure to get these approvals might attract severe penalties. Hence, it becomes very important to get the medical devices registered every time and prevent yourself from any sanction.
Patents, Patent Evaluations & Patent Protection
Since a large portion of pharmaceutical company’s revenue is generated from their patents, protecting novel methods of treatment and innovations in the pharmaceutical industry is critical for drug developers. Once a patent expires, the other drug manufacturing companies can manufacture and sell such drugs. Our patent practitioners can help you ensure your patents are valid, broad enough to cover your products, and extended for their maximum period.
Regulatory Compliances & Approvals
Compliance encompasses everything ranging from ensuring that the products are safe and effective to making sure that the marketing materials are accurate. The consequences of non-compliance can range from financial penalties to criminal charges as well. The compliance procedures in the pharmaceutical industry are updated and revised regularly and often. This means that companies must keep updating their internal mechanisms and ensure that their employees are also aware of the current regulations that are prevailing in the market. Regular monitoring of such compliances is integral in order to ensure that the drugs produced by them are safe and effective.
Sale & Labeling Compliances
The labelling of pharmaceutical products is highly regulated and plays a significant role in getting product approvals as well as maintaining the safety of your products. The labels used on pharmaceutical products are important – not just to make customers aware of the specific formulae used – but also to protect them from incorrect usage of the formulae. There exist government authorities which provide rules and regulations to regulate the product packaging and labelling – and packaging alone can provide a reason to recall your products. In order to avoid product recalls and ensure success for the product, the companies must inspect every step of the production and ensure that the most recent and appropriate information is labelled on the product.
Contract Analysis, Drafting & Management
In a highly regulated industry, understanding the key challenges of negotiation and drafting effective contracts is a highly complex skill. With pharmaceutical & cosmetics manufacturers constantly striving to innovate and improve their services, it is essential to ensure your contracts are complied, constantly managed, and properly tailored to your purposes – else you risk losing your gains to excessive liabilities, penalties and restrictions. Our team of expert medical lawyers can help in drafting and managing these contracts for your establishment.