0

How can small-mid scale bio-pharma fast track their clinical development & product registration processes? Leveraging secrets of a global network

Credevo Global Network for Clinical Development and Product Registrations

Cost and time for clinical development constitute more than 70% of the total development of any drug! Small – mid-scale biopharma are known for their innovative approaches, agility, and faster developments. However, clinical development has always been one step too important, yet too hard for them. There are ways to overcome these challenges and optimize […]

Read More →
0

How To Choose a CRO?: Small and Mid-Size Pharma Companies

CRO (Contract Research Organizations) for small and mid size pharma

Most of the small and mid-size pharma are stressed out while outsourcing pre-clinical and clinical development to CRO (Contract Research Organization). Selection factors differ while choosing CRO for large and small-medium scale companies. These include factors like budgeting, multiple region selection, and approaches. Increased outsourcing is seen in pharmaceutical and biotechnology companies, with 85 percent of […]

Read More →
0

Rare Diseases: Patient Recruitment Strategies in Clinical Trials

patient recruitment in rare disease clinical trials

Patient recruitment in rare disease clinical trials presents several difficulties. These challenges include limited eligible patients, dispersed geographic distribution, low disease awareness, site and investigator identification difficulties, and ethical considerations. They hinder participant enrollment and cause trial completion delays. Over the past few years, the rate of drug development in rare diseases has been increasing. […]

Read More →
0

Regulatory Approval For Nutraceuticals (Complementary Medicines) In Australia Part-III

Complementary medicines/nutraceuticals approval process in Australia

Do you know? Global regulators consider Australian Nutraceuticals complementary medicines () the consumer protection benchmark. In Australia and internationally, numerous complementary medicines are considered premium brands. That is obvious because the complementary medicines’ approval follows a strict regulatory regime and is one of the stringent in the world!. With such high quality of these products, the Australian complementary […]

Read More →
1

What You Need to Know to Register Nutraceutical, Dietary Or Food Supplement Products In Europe – Part I

Nutraceuticals, dietary supplements, or food supplements, also known as “Health Supplements,” have been used for years to maintain, enhance, and improve the healthy function of the human body. They may contain a combination of vitamins, minerals, amino acids, fatty acids, enzymes, probiotics, and other bioactive substances. Each country differs in its regulatory requirements for registration […]

Read More →
2

Regulatory Approval For Nutraceuticals (Complementary Medicines) In Australia Part-II

Concerning the safety, efficacy, and quality of the product, Australian regulators review and register nutraceuticals, same as pharmaceutical products, concerning the safety, efficacy, and quality of the product. To register herbal, animal, cosmetics, vitamins, or mineral products in Australia, one needs to take the route of the Complementary registration process. Read the first part of […]

Read More →
1

What would you ask China FDA officials that can improve your clinical trials and product registrations experience in China?

Revised Chinese regulations that brought a lot of changes in clinical trials and product registrations were received with lots of questions. If you have got questions that are yet unanswered, you are not alone. Many researchers, developers, and managers are not sure about one aspect or another on how to comprehend, act, or change their […]

Read More →
2

Clinical Trial Requirements and Practical Scenario for Marketing Approval in China

Clinical trial requirements and practical scenario for marketing approval in China

Do you know any product segment where one does not get to encounter Chinese products? Well, hardly any. It has been the focus of the Chinese government for the past several decades to dominate various industrial sectors, including pharmaceuticals. While China has been the big production factory for generic drugs and API ingredients for many […]

Read More →
0

Rare Diseases: Pre-Clinical Studies And Clinical Trials In Orphan Drug Development

The development of drugs in rare diseases provides great opportunities to pharma companies along with challenges that are required to overcome during drug discovery, pre-clinical, and clinical stages of drug development. Commercially rare diseases drug development differs from traditional diseases, as there are considerably few patients to take the drug, therefore pharmaceutical companies should consider […]

Read More →
2

Regulatory Approval For Nutraceuticals (Complementary Medicines) In Australia Part-I

Regulatory approval process for Nutraceuticals/Complementary medicines in Australia

Do you wish to market your nutraceuticals/complementary medicines (vitamins, minerals, nutraceutical products, dietary supplements, and herbal products) in the Australian market? Then it is better to realize that the Australian regulatory requirements are different from other countries for such products. For example, in the United States of America (USA), by filing the GRAS status (Generally Recognized […]

Read More →