Pharmaceutical & Biotechnology

We assist global pharmaceutical and biotechnological companies to meet statutory and regulatory requirements in the markets where they operate, as well as in their M&A, drug marketing and other endeavors.

 

 

We may assist you in the fields of personal and corporate data protection, regulatory compliance on drug manufacturing and applicable code of conduct, drug import, (EMEA) marketing authorization, advertising and promotion regulations, distribution and sales, public private partnerships.

Bulgaria is also an internationally recognized market for clinical trials conduct.

 

CASE STUDY

CLINICAL TRIAL CONDUCT, PERSONAL DATA PROTECTION AND ETHICS CODES

We are experienced in assisting global pharmaceutical companies in complying with applicable standards of ethics and with Good Clinical Practice, including all aspects of personal data protection.

We are able to prepare and handle for you summaries of multiple key provisions from sophisticated clinical trial site agreements and other clinical trial related documentation that will ultimately streamline the clinical trial process.

REGULATORY COMPLIANCE FOR DRUG MANUFACTURING, IMPORT, MARKETING AUTHORIZATION,
ADVERTISING AND DISTRIBUTION

 

BUSINESS CASE AND SOLUTION

We have been part of an international team of attorneys, having both local and international qualifications and experience, to promptly service with first-class quality and speed urgent agreement summarization requests, and deal with regulatory compliance of clinical trials.

We are also advising pharmaceutical companies on competition and regulatory matters, drug import, marketing authorization, advertising and distribution.

 

The new European Union Clinical Trials Regulation (CTR) EU No 536/2014 .

The rules for conducting clinical trials to become identical throughout the EU.

 

BENEFITS FOR THE CLIENT

Getting access to top-class quality attorney-level resources, assisting you in a way to reduce the administrative burden in submission of clinical trial applications.

Our ability to scale the multilingual team is crucial for promptly meeting the client needs.

The client gets high perception of value for money in managing high volume tasks.