Our quality assurance, quality control and regulatory affairs departments give the necessary support at all development stages.

Over the past three decades, BCN Peptides has accumulated extensive manufacturing,
analytical and regulatory expertise and has set the standards for the peptide industry. We offer a wide range of API services and we accompany our clients through all clinical phases up to market approval.

GMP Manufacturing

We are experts in the Solid Phase Synthesis of peptides. We manufacture from milligrams to multi kg batches of GMP Peptides and we are specialists in long sequences and cyclic peptides.

We can support you in all the different phases:

  • R&D (Route development)
  • Scaling up
  • Process Validation
  • Commercial Manufacturing
  • GMP production of both sterile and non-sterile API

BCN Peptides’ manufacturing facilities comply with the Good Manufacturing Practice (GMP) standards. We have an excellent track record of successful inspections by Global Health Agencies (US FDA, EDQM, KFDA,…).

Our state of the art facility has been specially designed by BCN Peptides applying all our know-how in Solid Phase Synthesis.

We work in close collaboration with our customers to meet ambitious deadlines, produce an excellent quality product and ensure process efficiency.

Analytical support and capabilities

Throughout the development and industrial lifecycle of all our APIs, we provide analytical support to contracted customers as required for cGMP compliance.

We have extensive analytical expertise and offer all analytical services to ensure successful product development. Our vast platform of state-of-the-art analytical techniques is designed to meet all regulatory requirements for our products throughout the entire product life cycle.

We offer a wide range of GMP compliant analytical services for our customers:

· Characterization
· Working Standard Preparation
· Establishment of Specifications
· Analytical Method development and Validation
· ICH Stability Studies
· Analysis of pharmaceutical final product

Regulatory affairs services

BCN Peptides brings together a legacy of experience in successfully managing the complex regulatory and registration processes required for peptides. In addition to compiling and submitting regulatory documents for pharmaceutical substances in Europe, US and Japan, BCN Peptides also has extensive regulatory experience worldwide.

Our Regulatory Affairs team has experience in writing different types of regulatory dossiers, such as:

· Drug Master Files
· EP-Certificates of Suitability (CEP)
· Regulatory Support

As required we support approvals of our contracted customers' NDAs and MAAs during registration as well as post-approvals through response to questions issued by the authorities.

Project Management

Our dedicated and experienced project managers ensure the development and manufacture of your product through close collaboration with the project team. In addition, we apply industry-recognised methodologies at every stage of development, ensuring a fundamental approach to analyse and monitor your project through to completion.