Our internationally experienced specialists have detailed know-how in the planning and preparation of dossiers, e.g. European ASMF (Active Substance Master File), US-DMF (Drug Master File), certificate of suitability (CEP). We prepare regulatory documents for your global submission. For the start of the clinical trial the CTA (Clinical Trial Application) needs to be submitted in EU, and the IND (Investigational New Drug Application) needs to be submitted in US. These are the documents which we will be elaborated with you and will be written for you. Regulatory submissions entail a large variety of documents. We are here to advice you on how to structure and write these documents, and MedicGLP we are prepared to take up this task for you, e.g. SPCs (Summary of Product Characteristics), clinical or nonclinical study protocols and reports, clinical or non-clinical summaries and overviews, Quality Overall Summaries (QOS) as well as CMC documents. We guide your project through the regulatory process, elaborate regulatory strategies for European and US-filings, and help you in the preparation of meetings with Authorities (national agencies, EMA, FDA). However, a successful submission also depends on compliance with GMP / GCP and GLP standards. We check your compliance status during mock inspections. We help you to ensure adherence to EU and US-requirements and support you in setting up adequate quality systems by writing SOPs and performing training for your personnel.

Science continues to prove that the old adage "you are what you eat" is profoundly true. This is because you have trillions of microorganisms living in your gut, which are directly responsible for nearly every aspect of your health. These microbes make up what’s called your "gut microbiota." They are especially influential in determining your likelihood of gaining excessive weight, MedicGLP Online becoming obese, and developing obesity-related diseases like diabetes, heart disease, and premature death. The gut microbiome (the expressed genes of your gut microbiota) plays a major role in your metabolism through energy production, storage, and expenditure. So, it’s no surprise that science has found a strong connection between gut microbiome imbalance and metabolic syndrome. Yikes! If you have the wrong mix of microbes, it could be making it tough for you to get your health on track! Did you know: Scientists can actually look at your gut microbiome composition and MedicGLP tell with 90% accuracy if you are obese or lean. That’s pretty impressive, isn’t it?

1. Unable to lose weight and keep it off? 2. Struggling to fight cravings? 3. Sick of starving yourself for weight loss? 4. Baffled as to why no diet seems to really work for you? Depending on the composition of your gut microbiome, your microbes can either boost your health or weigh you down (figuratively and literally). The good news is this: You have control over these little guys with every bite you eat. Diet has the power to change the landscape of your gut microbiome. So, if you’ve tried multiple diets and can’t seem to get the results you want, it’s time to look into your gut microbiome.Will You Lose Weight Naturally on an Individualized Diet? If you’ve been struggling to lose weight and keep it off - it could be your gut microbiome. While Viome doesn’t guarantee weight loss, it has been an exciting result many of our customers have reported. "Fiona’s update day 37!

We know weight loss can be tough. Find out if your weight struggles are due to a gut microbiome imbalance with Viome - and let’s tip the scales in your favor. Your gut microbes actually digest much of your food for you. When your gut microbiota help digest your food, they turn it into nutrients, neurotransmitters, vitamins, hormones, and more. Through these metabolites, the composition of your gut microbiome influences nearly every metabolic activity. It’s accurate to think of your gut microbiome as an organ that’s part immune system and part energy regulator. If your gut microbiome is imbalanced, certain bacteria end up working to protect themselves from the harsh environment and are not able to help you. In the worst case scenario, you can have microbiota adding to your health problems, making it harder for you to get healthy and lose weight. Viome’s metatranscriptomic technology has allowed us identify microbial pathways and functions, specifically those that influence weight loss or gain.

Want to dig deeper? Here are 3 major mechanisms that affect weight loss or gain through different microbial pathways. Butyrate - Butyrate helps combat obesity through increasing satiety (feeling of fullness), and reducing overall inflammation. Low grade inflammation is a big contributor to weight gain. Propionate - Similar to butyrate, propionate also helps fight weight gain through stimulating satiety and reducing inflammation. Acetate - Acetate is responsible for modulating the production of insulin. Higher insulin levels increase fat storage and prevent the body from releasing it for energy production. Acetate made by microbes actually signals the brain to make more insulin, leading to weight gain. Each of these are created from many different substrates (elements found in your food) and play a critical role in regulating your weight. What the microbes are making them from (ie. Viome’s recommendations are aimed at influencing the production of these various short chain fatty acids through supplying the right food and supplements. Your recommendations are based on what your microbes are currently doing and what can be done to shift them to function better.