Regulatory Affairs

Aptar Pharma's specialized analytical, development and regulatory services contribute value throughout the entire drug development process, expediting progress and mitigating risks along the journey.

Avéma Pharma Solutions can help guide your product successfully through NDA, ANDA, CBE 30 and 505(b)(2) filings with the FDA.

From pre-clinical development to commercial supply, Patheon by Thermo Fisher Scientific is an industry leader in the development and manufacture of mammalian cell culture drug substances. Patheon offers biotech and pharmaceutical companies the ability to pursue opportunities around the globe with a fully i...

Selectchemie AG provides a wide range of services including scientific support. Our experienced professionals are at your service at locations in 18 countries to deliver tailor-made solutions according to your needs. Contact us for more information.

SUPPORT SERVICES FOR OUR CONTRACTED CUSTOMERS • Analytical Development • Validation Support • Regulatory Support • Clinical Supply Services

The compliance environment of the pharmaceutical and life science industry can offer very complex challenges. One issue is optimizing workplace technologies in the areas of Business Process Changes, Validation, and general GxP Compliance. At the same time, these challenges must be balanced with the develop...

Increase successful submission outcomes in markets worldwide with comprehensive, expertly analyzed regulatory and market access information: 

-Get treatments to patients faster Compare and monitor regulations quickly across markets to understand regional health technology assessment (H...

Continuous evolution in science and changes in the regulatory environment and health sector, creates the need for professional regulatory guidance throughout the lifecycle of a healthcare product.

Our 20 years of experience in multidisciplinary projects, along with our team’s continually grown k...

- Regulatory support
- Political and social scenarios analysis within the Brazilian Health Sector- Market analysis to provide strategic information on the Brazilian Health System including public and private sectors
- Regulatory intelligence strategy
- Compliance
- Due diligence
-...

Services supporting successful outcomes provided end-to-end

We help clients achieve positive regulatory outcomes using a scientific approach as the driver of success.
As the world’s leading provider of regulatory consulting services, we support our ...

With the growth in pharma manufacturing capability in Asia, each manufacturer nurtures an ambition to have their own footprint in the EU market. PharmSol, with its own setups in Germany and Malta, has created a platform which provides a comprehensive, integrated and seamless market access and supply c...

QEdge is an enterprise-wide Risk based, Quality management Software to ensure product Quality and regulatory compliance, and Audit Readiness.

·QEdge eQMS has configured 60 + Process

Data Integrity Part 11 (21 CFR Part 11, Annex 11) compliant Risk ...

I. SERVICES 1. Submission of ANDA, NDA and IND applications with NMPA; (including the whole service from GAP analysis, compiling, submission, sample testing, CDE review procedure tracking and supplemental info preparation); 2. GAP analysis and application strategies setup before the submission to NMPA; 3. ...

Genovior Biotechnology Corporation facility capabilities & current ongoing production lines

Over 400 developed recipes, 
including over 50 medical devices in various classes and indications,
in 20 pharmaceutical forms - 
everything starts in the Gofarm's R&D Laboratory.



In Gofarm's R&D Laboratory our and our clients' ideas take real shapes...

Recipharm offer formulation development services for all dosage forms. We develop everything from simple formulations for early studies to more complex formulations suited for commercialisation.

Rephine’s regulatory consultancy provides a complete portfolio of regulatory services to the pharmaceutical industry from clinical trial regulatory support to product life cycle management. Services include but are not limited to full clinical trial application (CTA) support, ...

CARBOGEN AMCIS has a track record, extending over 25 years, helping our customers transition their molecules from process development through validation and ultimately into commercial status. A range of services backed up with fully integrated support functions has been developed to facilitate and smooth t...

For pharmaceutical products, we offer support for regulatory services such as:
registration via national and European Union procedures;ANDA registration;
drafting of e-CTDs to create e-CTD sequences;
regulatory compliance;
minor and major variations (evaluation and/or management).For ...

Our formulation, device and development services are supported by our medical, regulatory, device vigilance and pharmacovigilance teams to safeguard your programme and ensure the smoothest path to product approval.

Our in-house team can support with:

Global regulatory development strategy...